Identity
- Trade Name
- Migun FDA UDI
- Generic Name
- Freestanding electric massager FDA UDI
- Device Name
- Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation. FDA UDI
- Model / Reference
- HY7000UM FDA UDI
- Description
- Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B556HY7000UM0 FDA UDI
- 510(k) Number
- K041200 FDA UDI
- FDA Product Code
- ISA FDA UDIILY FDA UDIJFB FDA UDI
- GMDN Term
- Freestanding electric massager FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 FDA UDI890.5500 FDA UDI890.5880 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-wearableFreestanding electric massagerTraction table, line-powered
Migun by Migun Life Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Migun Life Co., Ltd
Sources (1)
- FDA UDI 4c86023a-e366-4573-922b-818fd84b1f5f 35 fields · synced May 30, 2026