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510(k) Data Aggregation

    K Number
    K121820
    Device Name
    INWAVE
    Manufacturer
    ZYNEX MEDICAL, INC.
    Date Cleared
    2012-08-24

    (64 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Type
    Abbreviated
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InWave is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women.

    Device Description

    Non-Implanted Electrical Continence Device, Model InWave.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (Non-Implanted Electrical Continence Device, Model InWave). It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself (which is not provided here) or in a separate clinical study report.

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

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