BEUDAMED
    Product Code: QCI FDA class 2 21 CFR 882.5802

    Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

    Neurology

    The Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder is an external device that uses magnetic fields to induce neural activity in the cerebral cortex for the treatment of neurological and psychiatric disorders and conditions, specifically obsessive-compulsive disorder; it is not intended for focusing magnetic fields toward brain areas outside the cerebral cortex such as the cerebellum. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QCI under regulation 882.5802 in the Neurology specialty. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    10
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    9
    Years Active
    8

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    Basic Information

    Product Code
    QCI
    Device Class
    FDA class 2
    Regulation Number
    882.5802
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

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

    Definition

    External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 10 510(k) clearances via K numbers.

    K Number Device Name
    K260402 MeRT System
    K243459 Ultimate rTMS for OCD (M-series)
    K230657 BTL-99-OC
    K233742 CloudTMS Edge for OCD
    K231350 OCD MT Cap (85-00397-000)
    K221129 CloudTMS for OCD
    K212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
    K193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
    K183303 Brainsway Deep TMS System
    DEN170078 Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.