21 CFR 876.5320 — Stimulator, Electrical, Non-Implantable, For Incontinence

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5320

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).

Classification Rationale

Class II (performance standards).

Product Codes