Identity
- Trade Name
- Mphi 7 FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- The Mphi 7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It consists of a control unit which may be mounted on a mobile trolley and one or more connected applicator to delivery of visible/infrared laser light energy. FDA UDI
- Model / Reference
- F9000258 FDA UDI
- Description
- The Mphi 7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It consists of a control unit which may be mounted on a mobile trolley and one or more connected applicator to delivery of visible/infrared laser light energy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033765391207 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
No
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
Mphi 7 by Asa Srl — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Asa Srl
Sources (2)
- FDA UDI c5a7944a-9237-42b4-bac1-42e7e14eba1c 33 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 20, 2026