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510(k) Data Aggregation

    K Number
    K980567
    Device Name
    CHARGER (ED)
    Date Cleared
    1998-05-06

    (82 days)

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

    WALLING MEDICAL EQUIPMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.
    Device Description
    The Charger is used by impotent men to allow them to resume having sexual intercourse. It consists of a clear polycarbonate cylinder used as a vacuum chamber, that fits over the penis, and a vacuum pump with vacuum release trigger to evacuate air from the cylinder. As the air is removed from the chamber the negative pressure allows blood engorgement of the penis. When a sufficient erection occurs for vaginal penetration a Reliant constriction ring (K980567) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The kit comes with a set of 4 ring sizes. The pumps' ability to create a vacuum is limited by an automatic vacuum release valve so it cannot exceed the known safe limit of 17 in. Hg. The rings are elastic pharmaceutical quality material. The ring safety removal loops were performance tested for strength.
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    K Number
    K980752
    Device Name
    XTEND
    Date Cleared
    1998-05-06

    (75 days)

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

    WALLING MEDICAL EQUIPMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Xtend ring is used to maintain engorgement of the penis for men that are having difficulty with organic or psychological erectile dysfunction.
    Device Description
    The Xtend rings are used by men with erectile dysfunction to improve their ability to have sexual intercourse. When they have a sufficient erection for intercourse a Xtend constriction ring (K980752) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The Xtend ring kit consists of a set of 4 rings. The rings are elastic pharmaceutical quality material which come with an applicator and ring removal hooks. The ring safety removal loops were performance tested for strength. All warnings and precautions from the FDA internet address, www.fda.gov/cdch/ode/oxponrig.html, are included in the premarket notification.
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    K Number
    K971768
    Device Name
    RELIANT CHARGER
    Date Cleared
    1997-09-29

    (139 days)

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

    WALLING MEDICAL EQUIPMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reliant Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.
    Device Description
    Not Found
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