Ultimate rTMS
FDA 510(k) clearance K243460 · decided 2025-04-17
Clearance details
- K-number
- K243460
- Device name
- Ultimate rTMS
- Applicant
- Brain Ultimate, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-08
- Decision date
- 2025-04-17
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- OBP
- Device class
- 2
- Regulation number
- 882.5805
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MagVenture Accelerated TMS (aTMS) Therapy System (K260189) | Tonica Elektronik A/S | 2026-05-22 |
| Apollo TMS Therapy System;Apollo light TMS Therapy System (K260560) | Mag & More GmbH | 2026-05-22 |
| Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K253098) | Nexstim Oyj | 2026-03-20 |
| Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K252358) | Nexstim Oyj | 2026-03-20 |
| SPRY TMS Therapy System (0550) (K251653) | Soterix Medical, Inc. | 2026-02-20 |
| BrainsWay Deep TMS System (K251391) | Brainsway , Ltd. | 2025-11-07 |
| CloudTMS Edge (K250689) | Teleemg, LLC | 2025-09-14 |
| BrainsWay Deep TMS System (K251449) | Brainsway , Ltd. | 2025-09-13 |
| Apollo TMS Therapy System (K243700) | Mag & More GmbH | 2025-09-04 |
| Apollo TMS Therapy System (K243539) | Mag & More GmbH | 2025-08-18 |
| MagVenture TMS Therapy System (K251125) | Tonica Elektronik A/S | 2025-08-11 |
| MagVenture TMS Therapy System (K251119) | Tonica Elektronik A/S | 2025-08-08 |
Recalls involving this device
No recalls on record reference this clearance.