Identity
- Trade Name
- Human Tecar FDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- High-impedance CAP electrode, convex, thermodynamic Ø 40 mm FDA UDI
- Model / Reference
- CAP electrode convex Ø 40 mm FDA UDI
- Description
- High-impedance CAP electrode, convex, thermodynamic Ø 40 mm FDA UDI
Identifiers
- Catalog Number
- 16464 FDA UDI
- Primary DI / UDI-DI
- 08056182720900 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
Similar devices
Also classified as Medium-wave diathermy treatment system.
- Wonder Touch — XOD Inc · Class II
- COMPACT PLUS — INDIBA SA. · Class II
- INDIBA ACTIV - ACTIV 801 — INDIBA SA. · Class II
- INDIBA ACTIV - CT7 — INDIBA SA. · Class II
- INDIBA ACTIV - ACTIV 902 — INDIBA SA. · Class II
- GLOBUS — DOMINO SRL · Class II
- COMPACT LITE — INDIBA SA. · Class II
- INDIBA ACTIV - CT8 — INDIBA SA. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unibell Srl
Sources (1)
- FDA UDI 21f311dc-c72c-48ec-8e26-7d615c9fe44a 35 fields · synced May 30, 2026