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510(k) Data Aggregation

    K Number
    K250689
    Device Name
    CloudTMS Edge
    Manufacturer
    TeleEMG, LLC
    Date Cleared
    2025-09-14

    (192 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K173620,K173441
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CloudTMS Edge system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.

    Device Description

    The CloudTMS Edge is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.

    It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals.

    The CloudTMS Edge principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

    Area of the brain to be stimulated for MDD treatment is Left Dorsolateral Prefrontal Cortex.

    AI/ML Overview

    N/A

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