FDA UDI
In Commercial Distribution
🇺🇸 United States
Migun
DI: B556HY7770
·
Model: HY777
·
MIGUN LIFE CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Migun
- Primary DI
- B556HY7770
- Version / Model
- HY777
- Company Name
- MIGUN LIFE CO., LTD
- Labeler DUNS
- 689266158
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-01
- Public Version
- 5
- Public Version Date
- 2022-04-28
- Public Version Status
- Update
- Public Device Record Key
- bf6027a5-ee16-4fcb-9279-a14dbbdfcefa
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35147 | Musculoskeletal infrared phototherapy unit, non-wearable | A mains electricity (AC-powered) device intended 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B556HY7770 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041200 | 000 |