OBP · Class II · 21 CFR 882.5805

FDA Product Code OBP: Transcranial Magnetic Stimulator

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.

Leading manufacturers include Brainsway , Ltd., Magstim Company, Ltd. and Neuronetics, Inc..

66
Total
65
Cleared
156d
Avg days
2008
Since
66 devices
25–48 of 66
Cleared Oct 25, 2023
Magstim®Horizon® 3.0 TMS Therapy System
K232235
The Magstim Company , Ltd.
Neurology · 90d
Cleared Sep 13, 2023
Ultimate rTMS
K230735
Brain Ultimate, Inc.
Neurology · 181d
Cleared Apr 04, 2023
NeuroStar Advanced Therapy System (Version 3.7)
K230029
Neuronetics
Neurology · 90d
Cleared Mar 16, 2023
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
K223154
Magstim Company, Ltd.
Neurology · 161d
Cleared Jan 13, 2023
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
K222171
Magstim Company, Ltd.
Neurology · 176d
Cleared Sep 01, 2022
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
K220177
Magnus Medical, Inc.
Neurology · 223d
Cleared Aug 26, 2022
BrainsWay Deep TMS System
K220819
Brainsway , Ltd.
Neurology · 158d
Cleared Aug 24, 2022
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
K222230
Neuronetics, Inc.
Neurology · 30d
Cleared Jul 15, 2022
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
K220127
Neuronetics, Inc.
Neurology · 178d
Cleared Apr 06, 2022
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K220625
Remed Co., Ltd.
Neurology · 34d
Cleared Mar 04, 2022
BTL-995-rTMS
K212723
BTL Industries, Inc.
Neurology · 189d
Cleared Dec 10, 2021
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
K213543
Neuronetics, Inc.
Neurology · 32d
Cleared Nov 26, 2021
ALTMS Magnetic Stimulation Therapy System
K202537
Remed Co., Ltd.
Neurology · 451d
Cleared Sep 14, 2021
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
K211389
Magstim Company, Ltd.
Neurology · 132d
Cleared Aug 17, 2021
Deep Transcranial Magnetic Stimulation (DTMS) System
K210201
Brainsway , Ltd.
Neurology · 204d
Cleared Apr 23, 2021
Brainsway Deep TMS System
K203735
Brainsway , Ltd.
Neurology · 123d
Cleared Nov 20, 2020
NeuroStar Advanced Therapy
K201158
Neuronetics, Inc.
Neurology · 204d
Cleared Apr 03, 2019
HORIZON TMS Therapy System with Navigation
K183376
Magstim Company, Ltd.
Neurology · 118d
Cleared Mar 22, 2019
Nexstim Navigated Brain Therapy (NBT) System 2
K182700
Nexstim Plc
Neurology · 176d
Cleared Mar 15, 2019
HORIZON TMS Therapy System
K182853
Magstim Company, Ltd.
Neurology · 156d
Cleared Aug 14, 2018
Mag Vita TMS Therapy System w/Theta Burst Stimulation
K173620
Tonica Elektronik A/S
Neurology · 265d
Cleared Aug 03, 2018
HORIZON TMS Therapy System
K180907
Magstim Company, Ltd.
Neurology · 119d
Cleared May 04, 2018
Apollo TMS Therapy System
K180313
Mag & More GmbH
Neurology · 88d
Cleared May 03, 2018
Brainsway Deep (DTMS) System
K173540
Brainsway , Ltd.
Neurology · 169d