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PREMIO 10 - Moxa
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 111237
by Sedatelec
Identity
- Trade Name
- PREMIO 10 - Moxa EUDAMEDPREMIO 10 MOXA FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- PREMIO 10 - Moxa EUDAMEDThe PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following: • A handpiece with a Power Supply (110-240V~ /50-60Hz) • A tip concentrator • An user manual • A cover of arrangement The PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated. FDA UDI
- Model / Reference
- 111237 EUDAMEDPREMIO 10 FDA UDI
- Description
- The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following: • A handpiece with a Power Supply (110-240V~ /50-60Hz) • A tip concentrator • An user manual • A cover of arrangement The PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated. FDA UDI
Identifiers
- Catalog Number
- 111237 FDA UDI
- Primary DI / UDI-DI
- 03760262493107 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760262493107 EUDAMED
- 510(k) Number
- K101267 FDA UDI
- FDA Product Code
- ILY FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
PREMIO 10 - Moxa by Sedatelec — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101267 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-03760262493107 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sedatelec
- EUDAMED SRN
- FR-MF-000020946
Sources (3)
- EUDAMED 60cbb9aa-7c45-4b80-9592-b243b2f3bf1e 61 fields · synced Jul 12, 2026
- FDA UDI 5abe9e55-6514-435d-9c48-f65a4ed97445 38 fields · synced May 30, 2026
- FDA 510(k) K101267 1 fields · synced May 18, 2026