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 Tonica Elektronik A/S, Brainsway , Ltd. and Magstim Company, Ltd..

68
Total
67
Cleared
156d
Avg days
2008
Since
68 devices
49–68 of 68
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
Cleared Dec 13, 2017
Neurosoft TMS (also CloudTMS)
K173441
Teleemg, LLC
Neurology · 37d
Cleared Nov 10, 2017
Nexstim Navigated Brain Therapy (NBT) System 2
K171902
Nexstim Plc
Neurology · 137d
Cleared Oct 05, 2017
MagVita TMS Therapy w/MagPro R20
K172667
Tonica Elektronik A/S
Neurology · 30d
Cleared Sep 13, 2017
HORIZON Therapy System
K171051
Magstim Company, Ltd.
Neurology · 156d
Cleared Jul 25, 2017
MagVita TMS Therapy System
K171967
Tonica Elektronik A/S
Neurology · 25d
Cleared Jun 16, 2017
MagVita TMS Therapy System
K171481
Tonica Elektronik A/S
Neurology · 28d
Cleared May 01, 2017
MagVita TMS Therapy - w/MagPro R20
K170114
Tonica Elektronik A/S
Neurology · 109d
Cleared Mar 10, 2017
Rapid2 Therapy System
K162935
Magstim Company, Ltd.
Neurology · 141d
Cleared Dec 22, 2016
Neurosoft TMS
K160309
Teleemg, LLC
Neurology · 322d
Cleared Sep 11, 2016
NeuroStar TMS Therapy System
K161519
Neuronetics, Inc.
Neurology · 101d
Cleared Jun 10, 2016
NeuroStar TMS Therapy System
K160703
Neuronetics, Inc.
Neurology · 88d
Cleared Jul 31, 2015
MagVita TMS Therapy System
K150641
Tonica Elektronik A/S
Neurology · 142d
Cleared May 08, 2015
Rapid Therapy System
K143531
Magstim Company Limited
Neurology · 147d
Cleared Mar 28, 2014
NEUROSTAR TMS THERAPY SYSTEM
K133408
Neuronetics
Neurology · 142d
Cleared Apr 30, 2013
NEUROSTAR TMS THERAPY SYSTEM
K130233
Neuronetics
Neurology · 90d
Cleared Jan 07, 2013
BRAINSWAY DEEP TMS SYSTEM
K122288
Brainsway , Ltd.
Neurology · 161d
Not Cleared Oct 07, 2008
NEUROSTAR TMS SYSTEM
DEN070003
Neuronetics
Neurology · 502d