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510(k) Data Aggregation

    K Number
    DEN170023
    Device Name
    ThermoNeuroModulation Device, TNM Device
    Date Cleared
    2018-03-26

    (343 days)

    Product Code
    Regulation Number
    882.5893
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    Product Code :

    QAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.
    Device Description
    The TNM Device is a non-invasive, home-use, DC-powered medical device that consists of an over-the-ear Headset with earpieces that protrude into the external ear canals, a Control Unit with resistive touchscreen display, and a power cord. Optional accessories include a wedge pillow to support reclining during each treatment in place of a firm pillow, a stylus pen that can be used in place of a fingertip to interact with the display and prism spectacles that may be worn to enable reading and other visual relaxation activities during treatment. The TNM device uses a set of controlled thermal waveforms delivered to the anodized aluminum earpieces. The fluctuations interact with the patient's vestibular system, causing changes which can be used to treat migraine headaches.
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