(88 days)
The UROSTYM ™ Biofeedback and Stimulation Device is used for treating urinary incontinence by way of perineal re-education.. The Urostym probes are non-implanted electrical devices applied to the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. The probes and patches are provided nonsterile for single (individual) patient use / disposable. The probes are for office or hospital use under the direction of a physician or other licensed healthcare professional.
UROSTYM™ Biofeedback and Stimulation Device and Accessories
The provided document is a 510(k) summary for a medical device (UROSTYM™ Biofeedback and Stimulation Device and Accessories) and does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and is cleared for market.
Therefore, an answer fulfilling the request cannot be generated from the given 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).