Mega-Tms
Mega-Tms is a Class II device made by Neurosoft, Ooo, cleared under FDA 510(k) K192823 on 13 Aug 2021 and listed in FDA GUDID since 22 Aug 2021 (UDI-DI 04650075333174), active as of 21 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 | Number04650075333174 | Date22 Aug 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192823 | Date13 Aug 2021 | StatusActive |
Official records
- AccessGUDID record 04650075333174
- FDA 510(k) database K192823
Across registries
- FDA 510(k) K192823 decided 13 Aug 2021 Active
- FDA GUDID UDI-DI 04650075333174 listed 22 Aug 2021 Listed
Timeline
- Cleared FDA 510(k) K192823
- Listed FDA GUDID 04650075333174
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Magnetic neural stimulation system
- Model / reference
- MEGA-TMS
- Primary DI / UDI-DI
- 04650075333174
- 510(k) Number
- FDA product code
- GWF
- GMDN term
- Magnetic neural stimulation system
- Device class
- Class II
- Regulation number
- 882.1870
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Magnetic neural stimulation system.
- Belt by BTL Industries Limited
- MagPro MMC-90 9016E0211 by Tonica Elektronik A/S
- MagPro C-100 9016E0582 by Tonica Elektronik A/S
- Ultimate rTMS M-30 Ultimate by Shenzhen Yingzhi Technology Co., Ltd.
- Ultimate rTMS M-50 Ultimate by Shenzhen Yingzhi Technology Co., Ltd.
- Apollo Light TMS Therapy System 918010 by MAG & More GmbH
- Headrest by BTL Industries Limited