AccessGUDID - DEVICE: WiTouch Pro (00853096004021)

GUDID

Device Identifier (DI) Information

Brand Name: WiTouch Pro
Version or Model: 11.1500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11.1500
Company Name: HOLLYWOG, LLC

Primary DI Number: 00853096004021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043450879 *Terms of Use

Device Description: WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35372	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.	Active	false

FDA Product Code

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Product Code	Product Code Name
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171599	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Special Storage Condition, Specify: Store the device, remote control and gel pads in original packaging when not in use.
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 500 and 1060 KiloPascal
Storage Environment Atmospheric Pressure: between 500 and 1060 KiloPascal
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
Outer Diameter: 18 Millimeter
Height: 90 Millimeter
Width: 191 Millimeter

Device Record Status

Public Device Record Key: 58de1340-d853-4539-a4c9-cdaecd72c155
Public Version Date: October 23, 2019
Public Version Number: 2
DI Record Publish Date: July 10, 2018