AccessGUDID - DEVICE: COMFYCOMBPLUS (00816924020242)

GUDID

Device Identifier (DI) Information

Brand Name: COMFYCOMBPLUS
Version or Model: COMFYCOMBOPLUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: COMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLUS-TP,COMFYCOMBOPLUS-MFR
Company Name: Tensproducts, LLC

Primary DI Number: 00816924020242
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 104307787 *Terms of Use

Device Description: DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS

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
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071951	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 087ff86a-de46-4366-ba3e-bc3b08668d52
Public Version Date: June 02, 2023
Public Version Number: 5
DI Record Publish Date: November 21, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10816924020249	32	00816924020372	In Commercial Distribution	CASE- WITH 4040TC
00816924020372	1	00816924020242	In Commercial Distribution	KIT- WITH 4040TC
00816924020778	1	00816924020242	In Commercial Distribution	KIT-WITH KWTS22-MFR
10816924020775	32	00816924020778	In Commercial Distribution	CASE-WITH KWTS22-MFR
00816924020730	1	00816924020242	In Commercial Distribution	KIT-WITH KWTS22-TP