Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Regulation 882.5802
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QCI
| Company | 510(k)s | Recalls |
|---|---|---|
| Neuronetics | 2 | 0 |
| Teleemg, LLC | 2 | 0 |
| Brain Ultimate, Inc. | 1 | 0 |
| Brainsway , Ltd. | 1 | 0 |
| Brainways , Ltd. | 1 | 0 |
| BTL Industries, Inc. | 1 | 0 |
| Tonica Elektronik A/S | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2025 | K243459 | Ultimate rTMS for OCD (M-series) Brain Ultimate, Inc. | QCI |
| Feb 1, 2024 | K230657 | BTL-99-OC BTL Industries, Inc. | QCI |
| Dec 22, 2023 | K233742 | CloudTMS Edge for OCD Teleemg, LLC | QCI |
| Jun 8, 2023 | K231350 | OCD MT Cap (85-00397-000) Neuronetics | QCI |
| Mar 10, 2023 | K221129 | CloudTMS for OCD Teleemg, LLC | QCI |
| May 6, 2022 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy Sys Neuronetics, Inc. | QCI |
| Aug 9, 2020 | K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system Tonica Elektronik A/S, DK | QCI |
| Mar 8, 2019 | K183303 | Brainsway Deep TMS System Brainsway , Ltd., IL | QCI |
| Aug 17, 2018 | DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System Brainways , Ltd., IL | QCI |
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