Identity
- Trade Name
- Neuclare FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Device Name
- An electrically powered device with vibration probes, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating probes are interchangeable with others of different sizes and shapes. It is typically used to help reduce muscular tension or pain in the healthcare facility. FDA UDI
- Model / Reference
- B-01 FDA UDI
- Description
- An electrically powered device with vibration probes, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating probes are interchangeable with others of different sizes and shapes. It is typically used to help reduce muscular tension or pain in the healthcare facility. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800205600003 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Hand-held electric massager FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Hand-held electric massager
Neuclare by Deepsonbio Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Deepsonbio Co., Ltd
Sources (1)
- FDA UDI 25223b26-3597-47b9-8bd9-293ba95a75be 34 fields · synced Jun 1, 2026