e-vive NMES System with Post-Op Brace; Large/XL, Right (2.0 Dock) CY-1000-208

GUDID 00854691008339

e-vive NMES System with Post-Op Brace; Large/XL, Right (2.0 Dock)

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

• Primary Device ID: 00854691008339
• NIH Device Record Key: 6a3e74b7-2c06-4e68-b298-803c8752b43a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-vive NMES System with Post-Op Brace; Large/XL, Right (2.0 Dock)
• Version Model Number: CY-1000-208
• Catalog Number: CY-1000-208
• 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
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• 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	00854691008339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163067

FDA Product Code

• KQX: Goniometer, Ac-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: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-03-31

Devices Manufactured by CYMEDICA ORTHOPEDICS, INC.

• 00850022650000 - e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN): 2021-01-12 e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)
• 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)
• 00850022650024 - e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (ITALIAN): 2021-01-12 e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (ITALIAN)
• 00850022650031 - e-vive II NMES System with Post-Op Brace; S/M, Left (ITALIAN): 2021-01-12 e-vive II NMES System with Post-Op Brace; S/M, Left (ITALIAN)
• 00850022650048 - e-vive II NMES System with Post-Op Brace; L/XL, Left (ITALIAN): 2021-01-12 e-vive II NMES System with Post-Op Brace; L/XL, Left (ITALIAN)
• 00850022650055 - e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left (ITALIAN): 2021-01-12 e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left (ITALIAN)
• 00850022650062 - e-vive II NMES System; S/M, Right (ITALIAN): 2021-01-12 e-vive II NMES System; S/M, Right (ITALIAN)
• 00850022650079 - e-vive II NMES System; L/XL, Right (ITALIAN): 2021-01-12 e-vive II NMES System; L/XL, Right (ITALIAN)