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510(k) Data Aggregation

    K Number
    K070648
    Device Name
    THE INHIBITOR, MODEL 001
    Date Cleared
    2007-06-29

    (113 days)

    Product Code
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MELMEDTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used for the temporary relief of tinnitus. The unit emits an ultrasonic signal that masks or inhibits the sound of timitus in many afflicted individuals. The tip of the device is placed firmly against the bone behind the ear and held in place until the device goes off (60-90 seconds). This is a medical device and should only be used with the advice of a physician, audiologist or licensed hearing aid dispenser. Only adults 18 years of age and older should be dispensed an instrument.
    Device Description
    The Inhibitor" is a hand-held device that emits a ultrasonic signal in the range of 20 – 60 kHz (depending on the resonant frequency of the Piezo element used). It is powered by a 3.6 V Lithium ion rechargeable battery. The transducer is a piezoelectric element. The acoustic output is <100 mW/cm2.
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