Identity
- Trade Name
- BioStimul Handpiece FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- The BioStimul Handpiece is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscolar and joint pain and stiffness, minor arthrits pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles. The spot diameter at 1 cm out of the handpiece is 5 mm. The BioStimul Handpiece is supplied together with a suitable optical fiber. FDA UDI
- Model / Reference
- N378C1 FDA UDI
- Description
- The BioStimul Handpiece is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscolar and joint pain and stiffness, minor arthrits pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles. The spot diameter at 1 cm out of the handpiece is 5 mm. The BioStimul Handpiece is supplied together with a suitable optical fiber. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08034108512419 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
Category: Musculoskeletal infrared phototherapy unit, non-wearable
BioStimul Handpiece by Deka M.e.l.a. Srl — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
Sources (1)
- FDA UDI dd8c96f8-2308-45a0-949d-8f46e0857149 33 fields · synced Jun 9, 2026