AccessGUDID - DEVICE: ZOOM WELLNESS (06973351910028)

GUDID

Device Identifier (DI) Information

Brand Name: ZOOM WELLNESS
Version or Model: QY-S-BD-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kinreen Technology (Shenzhen) Co., Ltd

Primary DI Number: 06973351910028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 554534919 *Terms of Use

Device Description: The red light therapy bulb is made of red 660nm and near infrared 850nm which produces a wide range of health benefits . What’s Included : 1* Luxx Bulb 1* Remote Control 1* Power Clip Stand 1* Instruction Manual Insert the bulb into the power clip just like an ordinary light bulb , plug the bulb into the nearest wall socket than enjoy your red light at home . No need go to clinic and money – saving .

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):	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: 44d182b8-6fb5-4ec7-9204-4931ba881c78
Public Version Date: April 18, 2025
Public Version Number: 3
DI Record Publish Date: July 02, 2020