AccessGUDID - DEVICE: Pro Comfort Tens Unit Pads (00850632007218)

GUDID

Device Identifier (DI) Information

Brand Name: Pro Comfort Tens Unit Pads
Version or Model: SM120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7218
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00850632007218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: 2 pairs (4 pads total) of Tens Unit Pads for use with the Pro Comfort Tens Unit The life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation site. Electrode life may be extended by carefully following the instructions for use found in the manual. The expired electrodes are to be recycled and do not harm the environment.

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):	Yes
Over the Counter (OTC):	No
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?
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46ed4c22-ea27-4902-acc2-740b6c993fa6
Public Version Date: June 02, 2023
Public Version Number: 7
DI Record Publish Date: December 01, 2017