AccessGUDID - DEVICE: GB-3 (14897076720146)

GUDID

Device Identifier (DI) Information

Brand Name: GB-3
Version or Model: GD5208
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GD5208
Company Name: TENS PLUS INDUSTRIAL COMPANY

Primary DI Number: 14897076720146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 663211978 *Terms of Use

Device Description: Model GB-3 Device emits heat from the heater and treats the afflicted part of the body, hands, legs, knee, shoulder etc. by placing it near the surface of the bare skin (at a distance directly over the skin surface). It is effective when deep heating of body tissue is desired.

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?
35147	Musculoskeletal infrared phototherapy unit, non-wearable	An electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 6a46edf0-2559-4091-bf54-9e88d891f6b9
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: March 30, 2021