Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Neurology · 21 CFR 882.5802
External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).
Recent MDR events
11 adverse event reports on file
- NEUROSTAR ADVANCED THERAPYApr 16, 2026InjuryNeuronetics, Inc.3004824012-2026-00014
- TRANSCRANIAL MAGNETIC STIMULATIONSep 26, 2024InjuryUnkMW5160248
- RTMS FOR OCDFeb 12, 2024InjuryUnkMW5151360
- MAGSTIM RAPIDMay 31, 2022InjuryThe Magstim Company Limited8021774-2022-00001
- BRAINSWAYMay 20, 2022InjuryBrainsway Ltd.MW5109814
- NEUROSTIM TMS TREATMENTDec 3, 2021InjuryBrainsway Ltd.MW5105814
- BRAINSWAY DEEP TMS FOR OCDNov 15, 2021InjuryBrainsway Ltd.MW5105345
- HORIZONAug 10, 2021InjuryThe Magstim Company Limited8021774-2021-00012
- NEUROSTARFeb 2, 2021InjuryNeuronetics Inc.MW5099153
- TRANSCRANIAL MAGNETIC STIMULATORJan 5, 2021InjuryUnkMW5098697
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
24 firms currently registered for this product code
Brainsway Ltd.
Jerusalem, IL
Neurosoft Ltd
Ivanovo Ivanovskaya Oblast', RU
The Magstim Company Ltd.
Carmarthenshire Wales, GB
Tonica Elektronik A/s
FARUM Hovedstaden, DK
D&k Engineering, Inc.
San Diego, CA, US
Neuronetics Inc.
Malvern, PA, US
Spartronics Strongsville, Inc.
Strongsville, OH, US
Molex Llc
Naperville, IL, US
Domico Med-device, Llc
Fenton, MI, US
Nexstim Plc
Helsinki Uusimaa, FI
Magventure A/s
Farum Hovedstaden, DK
Mastars Industries Co., Ltd
Guangdong, CN
Yiwu Inwell Craft&gift Co.,ltd
Jin Hua Zhejiang, CN
Mag & More Gmbh
Munich Bavaria, DE
Shenzhen Yingchi Technology Co., Ltd.
Shenzhen Guangdong, CN
510(k) clearances
9 clearances for this product code
- Brain Ultimate, Inc.Apr 17, 2025
K243459 · Ultimate rTMS for OCD (M-series)
- BTL Industries, Inc.Feb 1, 2024
K230657 · BTL-99-OC
- Teleemg, LLCDec 22, 2023
K233742 · CloudTMS Edge for OCD
- NeuroneticsJun 8, 2023
K231350 · OCD MT Cap (85-00397-000)
- Teleemg, LLCMar 10, 2023
K221129 · CloudTMS for OCD
- Neuronetics, Inc.May 6, 2022
K212289 · NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
- Tonica Elektronik A/SAug 9, 2020
K193006 · MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system
- Brainsway , Ltd.Mar 8, 2019
K183303 · Brainsway Deep TMS System