ClearanceBrief
Panels › Neurology › Product code OBP · Class 2

Transcranial Magnetic Stimulator

Regulation 882.5805

9510(k)s in 12 months (69 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
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Top companies in OBP

Company510(k)sRecalls
Magstim Company Limited124
Neuronetics132
Tonica Elektronik A/S100
Brainsway , Ltd.80
Mag & More GmbH50
Brain Ultimate, Inc.30
Teleemg, LLC30
BTL Industries, Inc.20
Neuromodulatory Devices & Applications20
Nexstim Plc20
Decided510(k)Device and applicantCode
Sep 6, 2026K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
Fidelity BioPharma Co.
OBP
Aug 23, 2026K260691BTL-699
BTL Industries, Inc.
OBP
Aug 14, 2026K261228QuickVision Ultimate rTMS
Brain Ultimate, Inc.
OBP
May 22, 2026K260560Apollo TMS Therapy System;Apollo light TMS Therapy System
Mag & More GmbH, DE
OBP
May 22, 2026K260189MagVenture Accelerated TMS (aTMS) Therapy System
Tonica Elektronik A/S, DK
OBP
Mar 20, 2026K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
Nexstim Oyj, FI
OBP
Mar 20, 2026K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
Nexstim Oyj, FI
OBP
Feb 20, 2026K251653SPRY TMS Therapy System (0550)
Soterix Medical, Inc.
OBP
Nov 7, 2025K251391BrainsWay Deep TMS System
Brainsway , Ltd., IL
OBP
Sep 14, 2025K250689CloudTMS Edge
Teleemg, LLC
OBP
Sep 13, 2025K251449BrainsWay Deep TMS System
Brainsway , Ltd., IL
OBP
Sep 4, 2025K243700Apollo TMS Therapy System
Mag & More GmbH, DE
OBP
Aug 18, 2025K243539Apollo TMS Therapy System
Mag & More GmbH, DE
OBP
Aug 11, 2025K251125MagVenture TMS Therapy System
Tonica Elektronik A/S, DK
OBP
Aug 8, 2025K251119MagVenture TMS Therapy System
Tonica Elektronik A/S, DK
OBP
Jul 30, 2025K252032T65 (9016E061-)
Tonica Elektronik A/S, DK
OBP
Jun 27, 2025K251210Ampa One System (AMPA-001)
Neuromodulatory Devices & Applications
OBP
Apr 17, 2025K243460Ultimate rTMS
Brain Ultimate, Inc.
OBP
Mar 17, 2025K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro);
The Magstim Company Limited, GB
OBP
Feb 13, 2025K243319Ampa One System (AMPA-001)
Neuromodulatory Devices & Applications
OBP
Aug 30, 2024K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro);
The Magstim Company Limited, GB
OBP
May 31, 2024K222196Deep TMS System
Brainsway , Ltd., IL
OBP
May 24, 2024K232639Apollo TMS Therapy System
Mag & More GmbH, DE
OBP
Mar 22, 2024K231926NeuroStar Advanced Therapy System (All previously cleared models)
Neuronetics, Inc.
OBP
Feb 9, 2024K233631ZapStim Controller Application (Z1023)
Revital Lab, Inc.
OBP
Dec 29, 2023K232688NQ TMS for MDD (NQv1-MU-01)
Neuroqore, Inc.
OBP
Dec 13, 2023K233621NeuroStar Advanced Therapy System (Version 3.8)
Neuronetics
OBP
Oct 25, 2023K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 w
The Magstim Company , Ltd., GB
OBP
Sep 13, 2023K230735Ultimate rTMS; Yingchi rTMS
Brain Ultimate, Inc.
OBP
Apr 4, 2023K230029NeuroStar Advanced Therapy System (Version 3.7)
Neuronetics
OBP
Mar 16, 2023K223154Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
Magstim Company, Ltd., GB
OBP
Jan 13, 2023K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
Magstim Company, Ltd., GB
OBP
Sep 1, 2022K220177Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
Magnus Medical, Inc.
OBP
Aug 26, 2022K220819BrainsWay Deep TMS System
Brainsway , Ltd., IL
OBP
Aug 24, 2022K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental
Neuronetics, Inc.
OBP
Jul 15, 2022K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Neuronetics, Inc.
OBP
Apr 6, 2022K220625ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
Remed Co., Ltd., KR
OBP
Mar 4, 2022K212723BTL-995-rTMS
BTL Industries, Inc.
OBP
Dec 10, 2021K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Neuronetics, Inc.
OBP
Nov 26, 2021K202537ALTMS Magnetic Stimulation Therapy System
Remed Co., Ltd., KR
OBP
Sep 14, 2021K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
Magstim Company, Ltd., GB
OBP
Aug 17, 2021K210201Deep Transcranial Magnetic Stimulation (DTMS) System
Brainsway , Ltd., IL
OBP
Apr 23, 2021K203735Brainsway Deep TMS System
Brainsway , Ltd., IL
OBP
Nov 20, 2020K201158NeuroStar Advanced Therapy
Neuronetics, Inc.
OBP
Apr 3, 2019K183376HORIZON TMS Therapy System with Navigation
Magstim Company, Ltd., GB
OBP
Mar 22, 2019K182700Nexstim Navigated Brain Therapy (NBT) System 2
Nexstim Plc, FI
OBP
Mar 15, 2019K182853HORIZON TMS Therapy System
Magstim Company, Ltd., GB
OBP
Aug 14, 2018K173620Mag Vita TMS Therapy System w/Theta Burst Stimulation
Tonica Elektronik A/S, DK
OBP
Aug 3, 2018K180907HORIZON TMS Therapy System
Magstim Company, Ltd., GB
OBP
May 4, 2018K180313Apollo TMS Therapy System
Mag & More GmbH, DE
OBP

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