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510(k) Data Aggregation

    K Number
    K993343
    Device Name
    ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS
    Date Cleared
    2000-03-20

    (167 days)

    Product Code
    Regulation Number
    876.5020
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    Applicant Name (Manufacturer) :

    ERECXEL ENTERPRISES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ERECXEL Adjustable Penile Bands are indicated as over-the-counter treatment for men with erection problem due to penile venous leakage. During erection, the ERECXEL Adjustable Penile Bands device helps to produce penile rigidity by constricting the penile veins around the base of the penis to restrict the flow of blood from leaving the penis.
    Device Description
    ERECXEL Adjustable Penile Band is an external penile constriction device that is comprised of a split ring made of latex-free, bio-compatible rubberplastic. It is designed with fastening parts, consisting of interlocking teeth and cavities carried on each end of the ring. This simple mechanism permits the user to easily adjust the diameter of the device, allowing him to set its size to provide him the optimum degree of penile constriction that the device will effect during use. The device is designed with a urethral groove to allow the normal ejaculation process to occur during its use. It is also provided with tabs on each fastening end to facilitate its quick release from the penile shaft and is available in different sizes to accommodate the wide variation of penile sizes among men.
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