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510(k) Data Aggregation

    K Number
    K974082
    Device Name
    THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE
    Date Cleared
    1998-02-27

    (121 days)

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

    PERFORMANCE PLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis. The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.
    Device Description
    The Performance Plus Confidence rings are soft, pliable rings with a tab for removal. The E.I.D. system consists of a vacuum tumescence pump, a vacuum chamber with inserts, Confidence rings, lubricating gel, instructions for use, and a carrying case.
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