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510(k) Data Aggregation
K Number
K223884Device Name
ELITONE Urge Urinary Incontinence Device
Manufacturer
Date Cleared
2023-02-24
(59 days)
Regulation Number
876.5330Why 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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