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510(k) Data Aggregation

    K Number
    K020258
    Device Name
    SUPPORT SLEEVE
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    2002-04-04

    (69 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 :

    SUPPORT SLEEVE

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

    The intended use of the device is to assist users by supporting the penis during intimacy. Used by men with the inability to achieve vaginal penetration, due to a flaccid or partially erect penis.

    Device Description

    Support Sleeve

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Support Sleeve." It does not contain information about acceptance criteria or a study proving the device meets said criteria.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was cleared based on its substantial equivalence to an existing device, not on new performance data against specific acceptance criteria.

    Therefore, I cannot provide the requested information from the provided text.

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