Transcranial Magnetic Stimulator
Neurology · 21 CFR 882.5805
A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.
Recent MDR events
338 adverse event reports on file
- NEUROSTAR ADVANCED THERAPYJul 17, 2026InjuryNeuronetics Inc3004824012-2026-00018
- NEUROSTAR ADVANCED THERAPYJul 17, 2026InjuryNeuronetics Inc3004824012-2026-00019
- DEEP TRANSCRANIAL MAGNETIC STIMULATORJul 7, 2026InjuryBrainsway Ltd.3010300912-2026-24952
- NEUROSTAR ADVANCED THERAPYJul 2, 2026InjuryNeuronetics, Inc.3004824012-2026-00017
- NEUROSTAR ADVANCED THERAPYJul 1, 2026InjuryNeuronetics, Inc.3004824012-2026-00015
- NEURONETICS, INC.Jul 1, 2026InjuryNeuronetics, Inc.3004824012-2026-00016
- TMS ITBS-THETA BURST STIMULATIONJun 26, 2026MalfunctionUnkMW5189920
- DEEP TRANSCRANIAL MAGNETIC STIMULATORJun 21, 2026InjuryBrainsway Ltd.3010300912-2026-24722
- TRANSCRANIAL MAGNETIC STIMULATION (TMS) THERAPY SYSTEMJun 17, 2026InjuryUnkMW5189536
- NEUROSTAR TMSJun 4, 2026MalfunctionNeuronetics, Inc.MW5188934
Event type breakdown
Recalls
5 recall events for this product code
- Neuronetics, Inc.TerminatedMay 27, 2009
NeuroStar TMS Therapy System/SenStar Treatment Link.
SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor scalp burn to patients.
Z-1421-2009 · View FDA record ↗ - The Magstim Company LimitedOpen, ClassifiedUnknown
HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.
Z-0836-2019 · View FDA record ↗ - The Magstim Company LimitedTerminatedUnknown
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters
Users manuals not supplied with 4800-00T US Rapid Therapy System
Z-1352-2018 · View FDA record ↗ - The Magstim Company LimitedTerminatedUnknown
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
Z-1965-2020 · View FDA record ↗ - The Magstim Company LimitedTerminatedUnknown
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve s
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
Z-1966-2020 · View FDA record ↗
Registered firms
85 firms currently registered for this product code
Eemagine Medical Imaging Solutions Gmbh
BERLIN, DE
Neuronetics Inc.
Malvern, PA, US
Neurosoft Ltd
Ivanovo Ivanovskaya Oblast', RU
Nexstim Plc
Helsinki Uusimaa, FI
Magventure A/s
Farum Hovedstaden, DK
Yiwu Inwell Craft&gift Co.,ltd
Jin Hua Zhejiang, CN
Mag & More Gmbh
Munich Bavaria, DE
The Magstim Company Ltd.
Carmarthenshire Wales, GB
Brainsway Ltd.
Jerusalem, IL
Rmf Design And Manufacturing Inc.
Mississauga Ontario, CA
Kuro Medical
Eden Prairie, MN, US
Shenzhen Yingchi Technology Co., Ltd.
Shenzhen Guangdong, CN
Tonica Elektronik A/s
FARUM Hovedstaden, DK
Spartronics Strongsville, Inc.
Strongsville, OH, US
Brain Science Tools Bv
De Bilt Utrecht, NL
510(k) clearances
66 clearances for this product code
- Tonica Elektronik A/SMay 22, 2026
K260189 · MagVenture Accelerated TMS (aTMS) Therapy System
- Mag & More GmbHMay 22, 2026
K260560 · Apollo TMS Therapy System;Apollo light TMS Therapy System
- Nexstim OyjMar 20, 2026
K253098 · Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
- Nexstim OyjMar 20, 2026
K252358 · Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
- Soterix Medical, Inc.Feb 20, 2026
K251653 · SPRY TMS Therapy System (0550)
- Brainsway , Ltd.Nov 7, 2025
K251391 · BrainsWay Deep TMS System
- Teleemg, LLCSep 14, 2025
K250689 · CloudTMS Edge
- Brainsway , Ltd.Sep 13, 2025
K251449 · BrainsWay Deep TMS System