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510(k) Data Aggregation

    K Number
    DEN110011
    Device Name
    SYMPHONY DEVICE
    Date Cleared
    2013-12-18

    (889 days)

    Product Code
    Regulation Number
    882.5895
    Why did this record match?
    Product Code :

    OVP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose of the Symphony Device is to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counter-stimulation.
    Device Description
    The Symphony Device is a non-sterile, reusable, cloth-covered foam pad that contains six embedded electric motors that swing eccentric weights to produce vibration throughout the pad. The device is designed to be placed under the user's legs while sleeping. When the device is activated, an electronic controller runs a 35 minute preset vibration cycle. The controller allows the patient to control the intensity level of the vibration for the first 30 minutes of the cycle. In the last five minutes, the controller slowly ramps down the vibration intensity of the device and then automatically shuts the device off at the end of the timed cycle. One repeat cycle can be initiated by the patient. The controller contains the on/off function and has variable mechanical counter-stimulation intensity settings (1 to 9). The motor amplitude and frequency (vibration) can be set to different levels of intensity by means of a knob. The polyurethane foam pad is covered by an inner lycra cover and an outer cover. The outer cover on the Symphony™ Device is made of cotton. The device will be offered in three sizes: Small, Medium, and Large.
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