LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012670
    Device Name
    BOSS 2000-3 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
    Why did this record match?
    Device Name :

    BOSS 2000-3 VACUUM ERECTION DEVICE

    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

    This document package is a 510(k) premarket notification decision letter from the FDA regarding a vacuum erection device. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily states that the device, named "Boss-2000-3 Vacuum Erection Device (Over-the-Counter Use)", is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot provide the requested information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1