Clitoral engorgement device.

21 C.F.R. § 884.5970
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
(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.”

Starting a business? Corpus forms LLCs in all 50 states and DC.