Home GUDID 00853096004014 WiTouch
Primary DI 00853096004014
Brand WiTouch
Company HOLLYWOG, LLC
Model 11.1510
Catalog number 11.1510
Device description WiTouch brand over the counter transcutaneous electrical nerve simulator for analgesic pain relief in the lower back
Published 2016-09-20
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00853096004243 Package GS1 1 Not in Commercial Distribution 00853096004335 Package GS1 6 Not in Commercial Distribution 00853096004014 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00853096004243 00853096004243 853096004243 0853096004243 00853096004335 00853096004335 853096004335 0853096004335 00853096004014 00853096004014 853096004014 0853096004014
GMDN Terms# Term, Definition table Term Definition Analgesic transcutaneous electrical nerve stimulation system An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
Device Sizes# Type, Value, Unit table Type Value Unit Height 90 Millimeter Outer Diameter 18 Millimeter Width 191 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 500 KiloPascal 1060 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 50 Degrees Fahrenheit 104 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Store the device, remote control and gel pads in original packaging when not in use. Storage Environment Atmospheric Pressure 500 KiloPascal 1060 KiloPascal Storage Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 50 Degrees Fahrenheit 104 Degrees Fahrenheit
Regulatory Flags# DUNS number 043450879 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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