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510(k) Data Aggregation

    K Number
    K981011
    Device Name
    POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    1998-08-28

    (163 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Rejoyn Vacuum Erection Device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a letter from the FDA regarding a 510(k) submission for the "Rejoyn Vacuum Erection Device." It addresses the substantial equivalence of the device and its indications for use but does not include performance data, study results, or ground truth establishment.

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