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510(k) Data Aggregation

    K Number
    K081965
    Device Name
    MPOWRX SNORING SOLUTION
    Date Cleared
    2008-10-27

    (109 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPOWRX HEALTH AND WELLNESS PRODUCTS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.
    Device Description
    The MPowRxTM Snoring Solution is a simple one-piece, one-size-fits-all oral appliance used to prevent mild to moderate snoring. The MPowRx™ Snoring Solution is comfortably retained within the mouth while sleeping. The MPowRx™ Snoring Solution is fabricated from a common oral appliance material, fits between the lips and teeth, and has an aperture with a protrusion for holding the tongue. Once the protrusion is squeezed to reduce the air volume, a vacuum is formed which keeps the tongue comfortably retained within the protrusion. Forward retention of the tongue helps keep the upper respiratory air passages open to relieve snoring.
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