QB1 NMES SYSTEM, BILATERAL, LARGE/XLARGE QB-1000-252

GUDID 00854691008704

QB1 NMES SYSTEM, BILATERAL, LARGE/XLARGE

CYMEDICA ORTHOPEDICS, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00854691008704
• NIH Device Record Key: b625b27c-a203-4513-8c07-70be995b22c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QB1 NMES SYSTEM, BILATERAL, LARGE/XLARGE
• Version Model Number: QB-1000-252
• Catalog Number: QB-1000-252
• 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: true
• 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: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com
• Phone: 4806642547
• Email: jackie.c@cymedicaortho.com

Device Dimensions

• Length: 16 Inch
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• Length: 16 Inch
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• Length: 16 Inch
• Length: 16 Inch
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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854691008704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150413

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-06-21

Devices Manufactured by CYMEDICA ORTHOPEDICS, INC.

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• 00850022650017 - e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN): 2021-01-12 e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)
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