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510(k) Data Aggregation

    K Number
    K163448
    Device Name
    GrindCare System
    Manufacturer
    SUNSTAR SUISSE S.A.
    Date Cleared
    2017-09-01

    (267 days)

    Product Code
    HCC, KZM, NUW
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNSTAR SUISSE S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GrindCare System is indicated to aid in the evaluation and management of sleep bruxism by reducing the temporalis muscle EMG activity during sleep.
    Device Description
    The GrindCare System is a portable electromyographic (EMG), electrical stimulation, and biofeedback device. It consists of a Sensor that is adhered to the skin over the temporalis muscle by means of an adhesive, disposable, single-use GelPad. The System also includes a Docking Station, USB Cable, and Power Adaptor. The Sensor and Docking Station record and store EMG activity data, which is transferred from the Docking Station to the GrindCare Mobile App, which allows the user to review grinding and stimulation data and enter diary notes. The Sensor uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event.
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