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510(k) Data Aggregation

    K Number
    K983438
    Device Name
    MAX IT
    Manufacturer
    Date Cleared
    1999-02-08

    (132 days)

    Product Code
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOREA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation.
    Device Description
    The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation. This is achieved as a result of blood vessel constriction which allows blood to flow into the penis but not to freely flow out (the valvular effect). The external pressure applied by the Max-It device restricts the free flow of blood out of the penis, but not into the penis. It is equivalent to the venous flow controller in that it constricts the blood flow at the dorsal vein on top of the penis. It differs from the venous flow controller in that not only does it constrict blood flow at the dorsal vein on top of the penis, the Max-It device also constricts the three cavernous cylinders. These cylinders originate in the anus and transverses the perineum area to the pubis area which forms the base of the penis and extends into and forms the shaft of the penis. Pressure applied to this perineum area and dorsal vein and artery on the dorsal base of the penile shaft at the pubis, will provide the valvular control, which is the formula to natural erection.
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