Identity
- Trade Name
- Migun FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- Provides infrared heat to different areas of the body. It is indicated for the temporary relief of minor muscle and joint pain. the temporary relief of joint pain associated with arthritis. muscle spasms, minor sprains and strains, minor muscular back pain, muscle relaxation therapy and temporary increase of circulation where applied. FDA UDI
- Model / Reference
- HY777 FDA UDI
- Description
- Provides infrared heat to different areas of the body. It is indicated for the temporary relief of minor muscle and joint pain. the temporary relief of joint pain associated with arthritis. muscle spasms, minor sprains and strains, minor muscular back pain, muscle relaxation therapy and temporary increase of circulation where applied. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B556HY7770 FDA UDI
- 510(k) Number
- K041200 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Musculoskeletal infrared phototherapy unit, non-wearable
Migun by Migun Life Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Musculoskeletal infrared phototherapy unit, non-wearable.
- GameDay — Multi Radiance Medical · Class II
- SportLaser — Multi Radiance Medical · Class II
- Xianhe TDP Infrared Therapy Lamp — A & A Medical Supplies Co. · Class II
- Thermotex — Thermotex Therapy Systems Ltd. · Class II
- MR5 — Multi Radiance Medical · Class II
- Healthlight — HEALTHLIGHT LLC · Class II
- MR4 — Multi Radiance Medical · Class II
- MiS US — ASA SRL · Class II
Cleared under the same submission
K041200 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Migun Life Co., Ltd
Sources (1)
- FDA UDI bf6027a5-ee16-4fcb-9279-a14dbbdfcefa 34 fields · synced May 30, 2026