Identity
- Trade Name
- Human Tecar FDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- Straight Handpiece for Capacitive Electrodes (Metallic connection) FDA UDI
- Model / Reference
- Straight Handpiece (Metallic connection) FDA UDI
- Description
- Straight Handpiece for Capacitive Electrodes (Metallic connection) FDA UDI
Identifiers
- Catalog Number
- 16476 FDA UDI
- Primary DI / UDI-DI
- 08056182721013 FDA UDI
- 510(k) Number
- K181211 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Medium-wave diathermy treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medium-wave diathermy treatment system
Human Tecar by Unibell Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181211 also covers:
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
- Human Tecar — UNIBELL SRL
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
- Unibell Srl
Sources (1)
- FDA UDI 307fcd4e-e0c1-47d1-a1d9-ddf4cb377d7a 35 fields · synced Jun 8, 2026