e-vive NMES System CY-1000-120

GUDID 00854691008155

e-vive NMES System with Post-Op Brace; Extra Small, Left

CYMEDICA ORTHOPEDICS, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00854691008155
NIH Device Record Key89833b62-5956-4e55-bb03-e79c5a66be1a
Commercial Distribution StatusIn Commercial Distribution
Brand Namee-vive NMES System
Version Model NumberCY-1000-120
Catalog NumberCY-1000-120
Company DUNS035596579
Company NameCYMEDICA ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com
Phone4806642547
Emailjackie.c@cymedicaortho.com

Device Dimensions

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Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
Length16 Inch
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Length16 Inch

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 Percent (%) Relative Humidity and 106 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100854691008155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQXGoniometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2019-06-21

On-Brand Devices [e-vive NMES System]

00854691008131e-vive NMES System; Extra Small, Left
00854691008124e-vive NMES System; Extra Small, Right
00854691008117e-vive Bilateral NMES System; Extra Small
00854691008100e-vive Bilateral NMES System; 2X/3X
00854691008094e-vive Bilateral NMES System; Large/XL
00854691008087e-vive Bilateral NMES System; Small / Medium
00854691008070e-vive NMES System; Extra Small, Left, Bilateral Kit Label
00854691008148e-vive NMES System; with Post-Op Brace; Extra Small, Right
00854691008155e-vive NMES System with Post-Op Brace; Extra Small, Left

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