OBP · Transcranial Magnetic Stimulator

Neurology · 21 CFR 882.5805 · Class 2

Overview

Product CodeOBP
Device NameTranscranial Magnetic Stimulator
Regulation21 CFR 882.5805
Device ClassClass 2
Review PanelNeurology

Identification

A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.

Classification Rationale

Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.

Recent Cleared Devices (20 of 64)

Showing 20 most recent of 64 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjMar 20, 2026SESE
K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjMar 20, 2026SESE
K251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.Feb 20, 2026SESE
K251391BrainsWay Deep TMS SystemBrainsway , Ltd.Nov 7, 2025SESE
K250689CloudTMS EdgeTeleemg, LLCSep 14, 2025SESE
K251449BrainsWay Deep TMS SystemBrainsway , Ltd.Sep 13, 2025SESE
K243700Apollo TMS Therapy SystemMag & More GmbHSep 4, 2025SESE
K243539Apollo TMS Therapy SystemMag & More GmbHAug 18, 2025SESE
K251125MagVenture TMS Therapy SystemTonica Elektronik A/SAug 11, 2025SESE
K251119MagVenture TMS Therapy SystemTonica Elektronik A/SAug 8, 2025SESE
K252032T65 (9016E061-)Tonica Elektronik A/SJul 30, 2025SESE
K251210Ampa One System (AMPA-001)Neuromodulatory Devices & ApplicationsJun 27, 2025SESE
K243460Ultimate rTMSBrain Ultimate, Inc.Apr 17, 2025SESE
K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)The Magstim Company LimitedMar 17, 2025SESE
K243319Ampa One System (AMPA-001)Neuromodulatory Devices & ApplicationsFeb 13, 2025SESE
K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)The Magstim Company LimitedAug 30, 2024SESE
K222196Deep TMS SystemBrainsway , Ltd.May 31, 2024SESE
K232639Apollo TMS Therapy SystemMag & More GmbHMay 24, 2024SESE
K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc.Mar 22, 2024SESE
K233631ZapStim Controller Application (Z1023)Revital Lab, Inc.Feb 9, 2024SESE

Top Applicants

Innolitics

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