Identity
- Trade Name
- Migun FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- Migun HY7000U is a multi-function physio therapy table used primarily for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual and electric 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. FDA UDI
- Model / Reference
- HY7000U FDA UDI
- Description
- Migun HY7000U is a multi-function physio therapy table used primarily for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual and electric 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B344HY7000U0 FDA UDI
- 510(k) Number
- K041200 FDA UDI
- FDA Product Code
- ILY FDA UDIISA FDA UDIJFB FDA UDI
- GMDN Term
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI890.5660 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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Traction table, line-powered.
- Tradeflex Flexion Table — PIVOTAL HEALTH SOLUTIONS, INC. · Class I
- Roller Massage Table — Pivotal Health Solutions · Class I
- ALLEN — HILL-ROM, INC. · Class I
- CHATTANOOGA — DJO, LLC · Class II
- CHATTANOOGA — DJO, LLC · Class II
- Roller Massage Table — Pivotal Health Solutions · Class I
- Ergowave Roller Massage Table — PIVOTAL HEALTH SOLUTIONS, INC. · Class I
- Trademark Elevating Table — Pivotal Health Solutions · Class I
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 28954fc7-85fe-4c12-9dd2-32a9709c0d27 34 fields · synced Jun 8, 2026