Code of Federal Regulations (Last Updated: February 15, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 884 - Obstetrical and Gynecological Devices |
Subpart F - Obstetrical and Gynecological Therapeutic Devices |
§ 884.5970 - Clitoral engorgement device.
Latest version.
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§ 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.”
[65 FR 47306, Aug. 2, 2000]