CloudTMS Edge Main unit
CloudTMS Edge Main unit is a Class II device made by Neurosoft, Ooo, cleared under FDA 510(k) K250689 on 14 Sep 2025 and listed in FDA GUDID since 23 Jan 2026 (UDI-DI 04650075337783), 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 | Number04650075337783 | Date23 Jan 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250689 | Date14 Sep 2025 | StatusActive |
Official records
- AccessGUDID record 04650075337783
- FDA 510(k) database K250689
Across registries
- FDA 510(k) K250689 decided 14 Sep 2025 Active
- FDA GUDID UDI-DI 04650075337783 listed 23 Jan 2026 Listed
Timeline
- Cleared FDA 510(k) K250689
- Listed FDA GUDID 04650075337783
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CloudTMS Edge
- Generic name
- Magnetic neural stimulation system
- Model / reference
- Main unit
- Primary DI / UDI-DI
- 04650075337783
- 510(k) Number
- FDA product code
- OBP
- GMDN term
- Magnetic neural stimulation system
- Device class
- Class II
- Regulation number
- 882.5805
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code OBP (Transcranial Magnetic Stimulator).
- MagVenture TMS Therapy System by Tonica Elektronik A/S
- Headrest by BTL Industries Limited
- HORIZON TMS Therapy System by Magstim Inc.
- MagPro Accessories Pillow Case 70 cm (pack of 5pcs) 9016B0671 by Tonica Elektronik A/S
- KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100) by Fidelity BioPharma Co.
- Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) by Nexstim Oyj
- CloudTMS Edge by Teleemg, LLC
- Rapid2 Therapy System by Magstim Inc.
- NeuroStar TMS Therapy System by Neuronetics Inc.
- Belt by BTL Industries Limited