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510(k) Data Aggregation

    K Number
    K183468
    Device Name
    Revive Reusable Bladder Support
    Manufacturer
    Rinovum Subsidiary 2, LLC
    Date Cleared
    2019-01-25

    (42 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rinovum Subsidiary 2, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revive bladder support is intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
    Device Description
    The Revive bladder support reduces bladder leaks in women who are suffering from SUI by preventing or reducing unwanted urinary leakage. Use of the device is applicable for women who experience leakage when laughing, coughing, exercising, sneezing, etc. The device is not intended to treat women with urge incontinence. The shape of the Revive bladder support is designed to fit in the vaginal tract, and there is no sizing required. The device fits most users. The device can be worn daily for up to 12 hours. The Revive bladder support can be reused (and cleaned) for up to 31 times. Each packaged Revive bladder support device comes with the following: - · 1 Reusable Bladder Support - · 1 Reusable Applicator - · 1 Month Strings Supply - · Travel Case - · Instructions for Use
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