21 CFR § 876.5310 - Nonimplanted, peripheral electrical continence device.

---
identifier: "/us/cfr/t21/s876.5310"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.5310 - Nonimplanted, peripheral electrical continence device."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.5310"
section_name: "Nonimplanted, peripheral electrical continence device."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 876.5310 Nonimplanted, peripheral electrical continence device.

(a) *Identification.* A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.

(b) *Classification.* Class II, subject to the following special controls:

(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.

[65 FR 18237, Apr. 7, 2000]