CloudTMS Edge for OCD Main unit
CloudTMS Edge for OCD Main unit is a Class II device made by Neurosoft, Ooo, cleared under FDA 510(k) K233742 on 22 Dec 2023 and listed in FDA GUDID since 12 Jan 2024 (UDI-DI 04650075335895), 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 | Number04650075335895 | Date12 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233742 | Date22 Dec 2023 | StatusActive |
Official records
- AccessGUDID record 04650075335895
- FDA 510(k) database K233742
Across registries
- FDA 510(k) K233742 decided 22 Dec 2023 Active
- FDA GUDID UDI-DI 04650075335895 listed 12 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K233742
- Listed FDA GUDID 04650075335895
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CloudTMS Edge for OCD
- Generic name
- Magnetic neural stimulation system
- Model / reference
- Main unit
- Primary DI / UDI-DI
- 04650075335895
- 510(k) Number
- FDA product code
- QCI
- GMDN term
- Magnetic neural stimulation system
- Device class
- Class II
- Regulation number
- 882.5802
- GUDID distribution status
- In Commercial Distribution
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