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    K Number
    K990041
    Device Name
    UROSTYM BIOFEEDBACK AND STIMULATION PROBES
    Manufacturer
    LABORIE MEDICAL TECH CORP.
    Date Cleared
    1999-08-05

    (211 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UROSTYM BIOFEEDBACK AND STIMULATION PROBES

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

    The UROSTYM™ Biofeedback and Stimulation Probes are indicated for use in Treating urinary incontinence by way of re-education and stimulation. The UROSTYM non-implanted electrical Stimulation applied to the pelvic floor musculature and surrounding Pelvic Structures for therapy in the Treatment of urinary Incontinence. The probes are provided for single patient use/disposable. The non-steril probes are for office use under the direction of a physican or licensed health care professional.

    Device Description

    UROSTYM™ Biofeedback and Stimulation Device - Vaginal Probe Models 3AT2B and TP2B

    AI/ML Overview

    I'm sorry, but the provided text from the FDA letter and the "Indications For Use" form for the UROSTYM™ Biofeedback and Stimulation Device does not contain any information about acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested table or the details about a study, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided text.

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