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510(k) Data Aggregation

    K Number
    K223884
    Device Name
    ELITONE Urge Urinary Incontinence Device
    Manufacturer
    Date Cleared
    2023-02-24

    (59 days)

    Product Code
    Regulation Number
    876.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elidah Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ELITONE Urge is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.
    Device Description
    The ELITONE Urge Urinary Incontinence Device (hereafter ELITONE URGE or ELITONE UUI) provides electrical muscle stimulation (commonly called EMS or E-stim) to treat urge urinary incontinence. Stimulation is delivered to the pelvic floor muscles and surrounding structures through a disposable cutaneous electrode applied to the perineal region. One end of the thin, flexible electrode is positioned proximate the pubis and the other end is positioned proximate the ischial tuberosity. Mildly adhesive and electrically conductive hydrogel portions of each electrode to the perineal tissues and allow comfortable transfer of electrical stimulation through the pelvic floor. The stimulation is controlled by a battery powered, wearable control unit. The housing of the control unit is approximately 55mm x 45mm x 10mm. It includes two pushbuttons that allow the user to increment the voltage (i.e., intensity), and to start, pause and stop device operation. The stimulation utilizes a symmetric, amplitude-modulated, sinusoidal waveform. The output intensity operates over a range of levels (0-35) that approximately correspond to a 0-15mA RMS current. The stimulation frequency is 10 Hz, a frequency typically used to calm detrusor muscle activity, decreasing symptoms of urgency type incontinence. Each treatment session lasts 20 minutes, after which the device turns off automatically. Women are recommended to use the device 4-5 times per week.
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