(64 days)
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.
Non-Implanted Electrical Continence Device, Model InWave.
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.
§ 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).