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510(k) Data Aggregation

    K Number
    DEN110009
    Device Name
    RESTLESS LEG DEVICE
    Date Cleared
    2013-12-18

    (1056 days)

    Product Code
    Regulation Number
    890.5760
    Why did this record match?
    Product Code :

    OTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RESTIFFICTM Restless Leg Relaxer Foot Wrap is a prescription device intended to reduce symptoms of moderate to severe primary Restless Leg Syndrome (RLS) in adults and used during periods of rest or relaxation, when symptoms of RLS occur.
    Device Description
    The RESTIFFIC™ Restless Leg Relaxer Foot Wrap device is a foot wrap designed to apply continuous, adjustable squeezing pressure on specific muscles in the feet. The device is to be applied before bedtime or while the person is seated or supine. A more complete description of the device includes the following: - An outer cloth wrap to support and hold the pressure pad in place. (The wrap has an . open end so the pad can be removed and replaced, if needed. Only the cloth comes in contact with the skin); - . VELCRO straps and plastic buckles to hold the cloth wrap in place and allow for adjusting the pressure; and - Pressure pads of high density foam to put pressure on the medial and bottom part of ● the foot. The RESTIFFIC™ achieves its targeted pressure with a T- shaped pad that presses into the medial and bottom part of the foot.
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