ThermoTK
510(k) K213256
ThermoTK is a medical device (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K213256 on 25 May 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213256 | Date25 May 2023 | StatusActive |
Official records
- FDA 510(k) database K213256
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PBX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K213256
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Tecarpuls II 1731931 | 1731931 / 1731931 | 04053915986880 | — | On the market |
| ThermoTK 4802 | 4802 / 4802 | 04053815081296 | — | On the market |
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