ThermoTK 4802
ThermoTK 4802 is a medium-wave diathermy treatment system (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 and listed in FDA GUDID since 5 Jun 2023 (UDI-DI 04053815081296), 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 | GUDID listing | Number04053815081296 | Date5 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213256 | Date25 May 2023 | StatusActive |
Official records
- AccessGUDID record 04053815081296
- FDA 510(k) database K213256
Across registries
- FDA 510(k) K213256 decided 25 May 2023 Active
- FDA GUDID UDI-DI 04053815081296 listed 5 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K213256
- Listed FDA GUDID 04053815081296
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ThermoTK
- Generic name
- Medium-wave diathermy treatment system
- Model / Ref / Catalog
- 4802
- Primary DI / UDI-DI
- 04053815081296
- 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
Similar devices
Other devices filed under FDA product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).
- HEBE (NP0000763) by Novasonix Technology S.L.
- LB1 applicator AS100006 by Venus Concept Inc.
- NeoSculpt Plus by S&M Medical Co., Ltd.
- truSculpt iD by CUTERA, INC.
- PELLEFIRM by Ellman International, Inc.
- OptiLUV Device by POLLOGEN LTD
- Diacare 7000 by Globus Sport and Health Technologies, LLC
- V-IPL Optic set Full 6 filters VTL43050-6 by VIORA LTD
- Human Tecar HCR 1002 by Unibell S.R.L
- EmFace Device by Inmode MD, Ltd.