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510(k) Data Aggregation

    K Number
    K243289
    Device Name
    ADDNOX (BPSPM1)
    Manufacturer
    Nu Eyne Co., Ltd.
    Date Cleared
    2025-01-16

    (90 days)

    Product Code
    QGL
    Regulation Number
    882.5898
    Why did this record match?
    Product Code :

    QGL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADDNOX is indicated for the 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 ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
    Device Description
    The ADDNOX is a transcutaneous electrical trigeminal nerve stimulator for Attention Deficit Hyperactivity Disorder. It is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead. The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
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    K Number
    K232991
    Device Name
    BT-1000
    Manufacturer
    Bistos Co., Ltd.
    Date Cleared
    2024-08-28

    (341 days)

    Product Code
    QGL, OGL
    Regulation Number
    882.5898
    Why did this record match?
    Product Code :

    QGL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BT-1000 external Trigeminal Nerve Stimulation System 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 to be 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
    Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves with fine electrical stimulation using extracorporeal electrodes. The treatment protocol using the BT-1000 is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve via an electrode placed on the forehead.
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    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?
    Product Code :

    QGL

    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
    K213629
    Device Name
    SMILE
    Manufacturer
    Nu Eyne Co., Ltd.
    Date Cleared
    2023-02-12

    (452 days)

    Product Code
    QGL, OGL
    Regulation Number
    882.5898
    Why did this record match?
    Product Code :

    QGL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMILE external Trigeminal Nerve Stimulation (eTNS) System 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 to be 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
    Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder. A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead. The SMILE eTNS System treatment protocol is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve.
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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?
    Product Code :

    QGL

    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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