Ultimate rTMS for OCD (M-series)
FDA 510(k) clearance K243459 · decided 2025-04-17
Clearance details
- K-number
- K243459
- Device name
- Ultimate rTMS for OCD (M-series)
- 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
- QCI
- Device class
- 2
- Regulation number
- 882.5802
- 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 |
|---|---|---|
| BTL-99-OC (K230657) | BTL Industries, Inc. | 2024-02-01 |
| CloudTMS Edge for OCD (K233742) | Teleemg, LLC | 2023-12-22 |
| OCD MT Cap (85-00397-000) (K231350) | Neuronetics | 2023-06-08 |
| CloudTMS for OCD (K221129) | Teleemg, LLC | 2023-03-10 |
| NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (K212289) | Neuronetics, Inc. | 2022-05-06 |
| MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (K193006) | Tonica Elektronik A/S | 2020-08-09 |
| Brainsway Deep TMS System (K183303) | Brainsway , Ltd. | 2019-03-08 |
| Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (DEN170078) | Brainways , Ltd. | 2018-08-17 |
Recalls involving this device
No recalls on record reference this clearance.