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    K Number
    K113677
    Device Name
    GRINDCARE MEASURE
    Manufacturer
    MEDOTECH A/S
    Date Cleared
    2012-04-05

    (113 days)

    Product Code
    KZM
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDOTECH A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.
    Device Description
    GRINDCARE MEASURE is a portable electromyographic (EMG) monitoring device. The device consists of the recorder, a tri-polar electrode and a docking station. The electrode is placed on the forehead with three integrated electrodes in close connection to the temporalis muscle by means of a double-adhesive patch incorporating three conductive gelpads and connected to the recorder. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.
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    K Number
    K092675
    Device Name
    GRINDCARE
    Manufacturer
    MEDOTECH A/S
    Date Cleared
    2010-03-03

    (183 days)

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

    MEDOTECH A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.
    Device Description
    GRINDCARE is a portable electromyographic (EMG) and electrical stimulation device. The device consists of a stimulator, a docking station and a tri-polar electrode. The electrode is placed on the forehead with three integrated electrodes in close connection to the temporalis muscle by means of a double-adhesive patch incorporating three conductive gelpads and connected to the stimulator. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It 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. The EMG events are logged and stored on the device. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.
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