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510(k) Data Aggregation

    K Number
    K233293
    Device Name
    Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
    Manufacturer
    NeuroSigma, Inc.
    Date Cleared
    2024-01-16

    (109 days)

    Product Code
    QGL
    Regulation Number
    882.5898
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroSigma, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® ("Monarch Gen 2") is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
    Device Description
    The Monarch Gen 2 eTNS System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are: - . The Monarch® Gen 2 external pulse generator, which controls the electrical stimulation, and - The Monarch® NS-2 external (cutaneous) electrical patches, which are single-use disposable patches worn on the forehead (Figure 3).
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    K Number
    DEN180041
    Device Name
    Monarch eTNS System
    Manufacturer
    NeuroSigma, Inc
    Date Cleared
    2019-04-19

    (263 days)

    Product Code
    QGL, OGL
    Regulation Number
    882.5898
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroSigma, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
    Device Description
    The Monarch external Trigeminal Nerve Stimulation (eTNS) System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are: - The Monarch external pulse generator - The Monarch NS-2 external (cutaneous) electrical patches, which are single use disposable patches worn on the forehead. The device has two primary components A) an external pulse generator approximately the size of a cell phone, and B) the non-invasive electrical patch that patients apply to their forehead to receive therapy.
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