CloudTMS Edge Cooling unit
CloudTMS Edge Cooling 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 04650075333273), 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 | Number04650075333273 | Date23 Jan 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250689 | Date14 Sep 2025 | StatusActive |
Official records
- AccessGUDID record 04650075333273
- FDA 510(k) database K250689
Across registries
- FDA 510(k) K250689 decided 14 Sep 2025 Active
- FDA GUDID UDI-DI 04650075333273 listed 23 Jan 2026 Listed
Timeline
- Cleared FDA 510(k) K250689
- Listed FDA GUDID 04650075333273
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- Withdrawn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
- Cooling unit
- Primary DI / UDI-DI
- 04650075333273
- 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).
- MagPro MMC-140 9016E0573 by Tonica Elektronik A/S
- Magstim Horizon 3.0 TMS Therapy System by Magstim Inc.
- NeuroStar Advanced Therapy System (Version 3.8) by Neuronetics Inc.
- MagPro MCF-B65 9016E0423 by Tonica Elektronik A/S
- Ultimate rTMS M-30 Ultimate by Shenzhen Yingzhi Technology Co., Ltd.
- BrainsWay Deep TMS System by Brainsway, Ltd.
- NeuroStar Advanced Therapy Transcranial Magnetic Stimulator by Neuronetics Inc.
- ZapStim Controller Application Z1023 by Revital Lab, Inc.
- Brainsway Deep (DTMS) System by Brainsway, Ltd.
- QuickVision Ultimate rTMS by Brain Ultimate, Inc.