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Doctor Tecar Smart
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 10DTSModel DOCTOR TECAR SMART510(k) K183693
Identity
- Trade Name
- DOCTOR TECAR SMART EUDAMEDFDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- DOCTOR TECAR SMART EUDAMEDDoctor Tecar Smart is a diathermy product. This therapy increases the temperature in the body areas under treatment by means of a particular electric current, restoring the natural reparative capacity of the body. The dual delivery modes, capacitive and resistive, allow setting a specific treatment based on the disease to be cured, thus regenerating the tissues in depth. FDA UDI
- Model / Reference
- DOCTOR TECAR SMART EUDAMED10DTS EUDAMED1.1 FDA UDI
- Description
- Doctor Tecar Smart is a diathermy product. This therapy increases the temperature in the body areas under treatment by means of a particular electric current, restoring the natural reparative capacity of the body. The dual delivery modes, capacitive and resistive, allow setting a specific treatment based on the disease to be cured, thus regenerating the tissues in depth. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08051499970871 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08051499970871 EUDAMED
- 510(k) Number
- K221043 FDA UDI
- FDA Product Code
- PBX FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Medium-wave diathermy treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Doctor Tecar Smart by Mectronic Medicale Srl — Class IIb — 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 | K183693 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08051499970871 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mectronic Medicale srl
- EUDAMED SRN
- IT-MF-000040989
- FDA Applicant
- Mectronic Medicale S.R.L.
Sources (3)
- EUDAMED aab9b821-3fcb-4241-b508-24bc64bfc8c5 85 fields · synced Jun 19, 2026
- FDA UDI afda3a10-28a7-4849-93e1-d7ff635eb415 35 fields · synced May 30, 2026
- FDA 510(k) K183693 1 fields · synced May 18, 2026