Identity
- Trade Name
- NUGABEST FDA UDI
- Generic Name
- Bed/chair electric massager FDA UDI
- Device Name
- Personal heating therapeutic device FDA UDI
- Model / Reference
- N5-1 FDA UDI
- Description
- Personal heating therapeutic device FDA UDI
Identifiers
- Catalog Number
- N51-DM-11-2-022-01A-2 FDA UDI
- Primary DI / UDI-DI
- 08800091150132 FDA UDI
- 510(k) Number
- K153054 FDA UDI
- FDA Product Code
- JFB FDA UDI
- GMDN Term
- Bed/chair electric massager FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5880 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
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
Dimensions & Sizes
- Size
- Weight — 60 Kilogram FDA UDI
Nugabest by Nuga Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Nuga Medical Co., Ltd.
Sources (1)
- FDA UDI ed67a139-5a86-4491-b465-26bf5c82b64b 38 fields · synced May 30, 2026