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510(k) Data Aggregation

    K Number
    K971576
    Device Name
    REJOYN PENILE SUPPORT SYSTEM
    Manufacturer
    AMERICAN MEDTECH
    Date Cleared
    1997-10-16

    (174 days)

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

    AMERICAN MEDTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.
    Device Description
    The Rejoyn penile support system consists of a semi-rigid split support sleeve molded from medical grade rubber with an attachment strap. The sleeve is placed over the penis with the split side down and the strap is fastened behind the scrotum. The sleeve is approximately 2 1/4" long. The system may also include a lubricated latex cover which may be worn over the sleeve to enhance comfort. Another version of the Rejoyn system includes a single-use, disposable support sleeve in lieu of the reusable support sleeve. The single-use sleeve is made of the same materials as the reusable sleeve but is removed after use by breaking off one end of the attachment strap at a specified location. The Rejoyn system will be available in five different package variations: (1) one support sleeve, three covers and one tube of lubricating jelly; (2) one support sleeve and one tube of lubricating jelly; (3) one support sleeve and three covers; (4) three single-use support sleeves, three covers and one tube of lubricating jelly; and (5) three single-use support sleeves and three covers. Replacement covers and lubricating jelly also will be available separately.
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