AccessGUDID - DEVICE: Migun (B344HY7770)

GUDID

Device Identifier (DI) Information

Brand Name: Migun
Version or Model: HY777
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MIGUN LIFE INC

Primary DI Number: B344HY7770
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033919008 *Terms of Use

Device Description: Far Infra Red photo therapy unit indicated for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual massage, and is approved for relief of muscle and joint pain and stiffness, muscle relaxation, temporary increase in circulation and for temporary arthritis pain relief.

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?
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 [?]
K041200	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: 86758976-5609-4bc6-a1e2-a7623aa41c58
Public Version Date: April 18, 2025
Public Version Number: 6
DI Record Publish Date: September 22, 2016