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510(k) Data Aggregation

    K Number
    K974470
    Device Name
    VTU-E VACUUM ERECTION SYSTEM
    Manufacturer
    ENCORE, INC.
    Date Cleared
    1998-01-09

    (44 days)

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

    ENCORE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VTU-E is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
    Device Description
    The VTU-E™ consists of four silicone rubber constriction rings and a plastic penile cylinder attached to a battery-powered vacuum pump. The penis is placed into the penile cylinder and the vacuum pump is used to reduce the air pressure within the cylinder and thus cause a penile erection. Once the penis is erect, the silicone rubber ring is placed around the base of the penis in order to maintain the erection.
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