Human Tecar
Human Tecar (16480) is a medium-wave diathermy treatment system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Unibell SRL, cleared under FDA 510(k) K181211 on 10 Sep 2018 and listed in FDA GUDID since 15 Jun 2019 (UDI-DI 08056182721099), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08056182721099 | Date15 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181211 | Date10 Sep 2018 | StatusActive |
Official records
- AccessGUDID record 08056182721099
- FDA 510(k) database K181211
Across registries
- FDA 510(k) K181211 decided 10 Sep 2018 Active
- FDA GUDID UDI-DI 08056182721099 listed 15 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K181211
- Listed FDA GUDID 08056182721099
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Medium-wave diathermy treatment system
- Model / Ref / Catalog
- Steel Neutral Plate (Metallic connection), 16480
- Primary DI / UDI-DI
- 08056182721099
- 510(k) Number
- FDA product code
- PBX
- GMDN term
- Medium-wave diathermy treatment system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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