BEUDAMED
    Product Code: OBP FDA class 2 21 CFR 882.5805

    Transcranial Magnetic Stimulator

    Neurology

    The Transcranial Magnetic Stimulator (product code OBP) is a neurological treatment device that delivers brief duration, pulsed magnetic fields to induce electrical currents in spatially discrete regions of the cerebral cortex, specifically for the treatment of major depressive disorder (MDD). The device generates rapidly alternating magnetic fields applied non-invasively to the patient's scalp, targeting cortical areas involved in mood regulation. It is FDA Class 2 under regulation 882.5805 in the Neurology specialty, requiring 510(k) clearance and adherence to general and special controls. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    66
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    20
    Years Active
    18

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    Basic Information

    Product Code
    OBP
    Device Class
    FDA class 2
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 66 510(k) clearances via K numbers.

    K Number Device Name
    K260560 Apollo TMS Therapy System;Apollo light TMS Therapy System
    K260189 MagVenture Accelerated TMS (aTMS) Therapy System
    K253098 Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
    K252358 Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
    K251653 SPRY TMS Therapy System (0550)
    K251391 BrainsWay Deep TMS System
    K250689 CloudTMS Edge
    K251449 BrainsWay Deep TMS System
    K243700 Apollo TMS Therapy System
    K243539 Apollo TMS Therapy System
    K251125 MagVenture TMS Therapy System
    K251119 MagVenture TMS Therapy System
    K252032 T65 (9016E061-)
    K251210 Ampa One System (AMPA-001)
    K243460 Ultimate rTMS
    K243869 Horizon® 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)
    K243319 Ampa One System (AMPA-001)
    K241518 Horizon® 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)
    K222196 Deep TMS System
    K232639 Apollo TMS Therapy System
    K231926 NeuroStar Advanced Therapy System (All previously cleared models)
    K233631 ZapStim Controller Application (Z1023)
    K232688 NQ TMS for MDD (NQv1-MU-01)
    K233621 NeuroStar Advanced Therapy System (Version 3.8)
    K232235 Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
    K230735 Ultimate rTMS; Yingchi rTMS
    K230029 NeuroStar Advanced Therapy System (Version 3.7)
    K223154 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
    K222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
    K220177 Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
    K220819 BrainsWay Deep TMS System
    K222230 NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
    K220127 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
    K220625 ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
    K212723 BTL-995-rTMS
    K213543 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
    K202537 ALTMS Magnetic Stimulation Therapy System
    K211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
    K210201 Deep Transcranial Magnetic Stimulation (DTMS) System
    K203735 Brainsway Deep TMS System
    K201158 NeuroStar Advanced Therapy
    K183376 HORIZON TMS Therapy System with Navigation
    K182700 Nexstim Navigated Brain Therapy (NBT) System 2
    K182853 HORIZON TMS Therapy System
    K173620 Mag Vita TMS Therapy System w/Theta Burst Stimulation
    K180907 HORIZON TMS Therapy System
    K180313 Apollo TMS Therapy System
    K173540 Brainsway Deep (DTMS) System
    K173441 Neurosoft TMS (also CloudTMS)
    K171902 Nexstim Navigated Brain Therapy (NBT) System 2
    K172667 MagVita TMS Therapy w/MagPro R20
    K171051 HORIZON Therapy System
    K171967 MagVita TMS Therapy System
    K171481 MagVita TMS Therapy System
    K170114 MagVita TMS Therapy - w/MagPro R20
    K162935 Rapid2 Therapy System
    K160309 Neurosoft TMS
    K161519 NeuroStar TMS Therapy System
    K160703 NeuroStar TMS Therapy System
    K150641 MagVita TMS Therapy System
    K143531 Rapid Therapy System
    K133408 NEUROSTAR TMS THERAPY SYSTEM
    K130233 NEUROSTAR TMS THERAPY SYSTEM
    K122288 BRAINSWAY DEEP TMS SYSTEM
    K083538 NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
    DEN070003 NEUROSTAR TMS SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.