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510(k) Data Aggregation

    K Number
    K012672
    Device Name
    BOSS-2000-2 VACUUM ERECTION DEVICE
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    2001-11-09

    (88 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the 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

    The provided document is a 510(k) premarket notification approval letter for the "Boss-2000-2 Vacuum Erection Device." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    This letter primarily focuses on the regulatory determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It outlines general regulations and responsibilities but does not detail performance data, study designs, or acceptance metrics.

    Therefore, I cannot provide the requested information based on the given input text.

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