Compact Plus ACT0508
by Indiba SA.
Compact Plus (ACT0508USA) is a medium-wave diathermy treatment system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Indiba SA., cleared under FDA 510(k) K243164 on 20 Nov 2024 and listed in FDA GUDID since 29 Jan 2025 (UDI-DI 08434251004814), 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 | Number08434251004814 | Date29 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243164 | Date20 Nov 2024 | StatusActive |
Official records
- AccessGUDID record 08434251004814
- FDA 510(k) database K243164
Across registries
- FDA 510(k) K243164 decided 20 Nov 2024 Active
- FDA GUDID UDI-DI 08434251004814 listed 29 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K243164
- Listed FDA GUDID 08434251004814
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Compact Plus
- Generic name
- Medium-wave diathermy treatment system
- Model / Ref / Catalog
- ACT0508, ACT0508USA
- Primary DI / UDI-DI
- 08434251004814
- 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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