---
kind: "section"
citation: "21 C.F.R. § 876.5310"
title: "21"
number: "876.5310"
heading: "Nonimplanted, peripheral electrical continence device."
url: "https://uscodex.org/cfr/21/876.5310"
---

# §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](/cfr/21/801.109.md) 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)](/cfr/21/801.109.md?p=c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.

## Notes

### Amendments

[65 FR 18237, Apr. 7, 2000]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[65 FR 18237, Apr. 7, 2000]