ZShape RFG-01
ZShape RFG-01 (5570) is a radio-frequency physical therapy system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K240178 on 15 Jul 2024 and listed in FDA GUDID since 19 Jul 2024 (UDI-DI 04053815086369), 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 | Number04053815086369 | Date19 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240178 | Date15 Jul 2024 | StatusActive |
Official records
- AccessGUDID record 04053815086369
- FDA 510(k) database K240178
Across registries
- FDA 510(k) K240178 decided 15 Jul 2024 Active
- FDA GUDID UDI-DI 04053815086369 listed 19 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K240178
- Listed FDA GUDID 04053815086369
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ZShape
- Generic name
- Radio-frequency physical therapy system
- Model / Ref / Catalog
- RFG-01, 5570
- Primary DI / UDI-DI
- 04053815086369
- 510(k) Number
- FDA product code
- PBX
- GMDN term
- Radio-frequency physical therapy system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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