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510(k) Data Aggregation

    K Number
    K070331
    Device Name
    UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES
    Date Cleared
    2007-05-04

    (88 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    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 UROSTYM ™ Biofeedback and Stimulation Device is used for treating urinary incontinence by way of perineal re-education.. The Urostym probes are non-implanted electrical devices applied to the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. The probes and patches are provided nonsterile for single (individual) patient use / disposable. The probes are for office or hospital use under the direction of a physician or other licensed healthcare professional.

    Device Description

    UROSTYM™ Biofeedback and Stimulation Device and Accessories

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (UROSTYM™ Biofeedback and Stimulation Device and Accessories) and does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and is cleared for market.

    Therefore, an answer fulfilling the request cannot be generated from the given text.

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