---
kind: "section"
citation: "21 C.F.R. § 884.5970"
title: "21"
number: "884.5970"
heading: "Clitoral engorgement device."
url: "https://uscodex.org/cfr/21/884.5970"
---

# §884.5970. Clitoral engorgement device.

- (a) **Identification.** A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.
- (b) **Classification.** Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”

## Notes

### Amendments

[65 FR 47306, Aug. 2, 2000]

### Authority

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

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

[65 FR 47306, Aug. 2, 2000]