e-vive II NMES System CY-1000-319

GUDID 00854691008926

e-vive II NMES System with Post-Op Brace; XS, Right

CYMEDICA ORTHOPEDICS, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00854691008926
• NIH Device Record Key: 29bc7bca-6087-4695-9d03-f16aea3164e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-vive II NMES System
• Version Model Number: CY-1000-319
• Catalog Number: CY-1000-319
• Company DUNS: 035596579
• Company Name: CYMEDICA ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com
• Phone: 480-664-2547
• Email: jackie.c@cymedicaortho.com

Device Dimensions

• Length: 16 Inch
• Length: 16 Inch
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• Length: 16 Inch

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854691008926 [Primary]

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-12
• Device Publish Date: 2021-01-04

On-Brand Devices [e-vive II NMES System]

• 00854691008957: e-vive II NMES System; XS, Left
• 00854691008940: e-vive II NMES System; XS, Right
• 00854691008933: e-vive II NMES System with Post-Op Brace; XS, Left
• 00854691008926: e-vive II NMES System with Post-Op Brace; XS, Right
• 00854691008919: e-vive II NMES System; 2XL/3XL, Left
• 00854691008902: e-vive II NMES System; L/XL, Left
• 00854691008896: e-vive II NMES System; S/M, Left
• 00854691008889: e-vive II NMES System; 2XL/3XL, Right
• 00854691008872: e-vive II NMES System; L/XL, Right
• 00854691008865: e-vive II NMES System; S/M, Right
• 00854691008858: e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left
• 00854691008841: e-vive II NMES System with Post-Op Brace; L/XL, Left
• 00854691008834: e-vive II NMES System with Post-Op Brace; S/M, Left
• 00854691008827: e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right
• 00854691008810: e-vive II NMES System with Post-Op Brace; L/XL, Right
• 00854691008803: e-vive II NMES System with Post-Op Brace; S/M, Right