Globus Diacare 5500 Pro
by Domino SRL
Globus Diacare 5500 Pro (G6457) is a medium-wave diathermy treatment system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Domino SRL, cleared under FDA 510(k) K211207 on 6 Jun 2022 and listed in FDA GUDID since 4 Sep 2024 (UDI-DI 08032625821137), 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 | Number08032625821137 | Date4 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211207 | Date6 Jun 2022 | StatusActive |
Official records
- AccessGUDID record 08032625821137
- FDA 510(k) database K211207
Across registries
- FDA 510(k) K211207 decided 6 Jun 2022 Active
- FDA GUDID UDI-DI 08032625821137 listed 4 Sep 2024 Listed
Timeline
- Cleared FDA 510(k) K211207
- Listed FDA GUDID 08032625821137
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Globus
- Generic name
- Medium-wave diathermy treatment system
- Model / Ref / Catalog
- DIACARE 5500 PRO, G6457
- Primary DI / UDI-DI
- 08032625821137
- 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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