(67 days)
Everyway Incontinence Stimulation System is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Everyway Incontinence Stimulation System ( Stimulator models EM-2400 and EM-5300 with Vaginal Probe models PR-02A, PR-04A and PR-14A )
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Everyway Incontinence Stimulation System." The document is a 510(k) clearance letter from the FDA, which primarily states that the device has been found substantially equivalent to predicate devices and outlines regulatory requirements. It does not include details about specific performance metrics or clinical study results.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).