part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
subpart_code: "F"
subpart_subject: "Obstetrical and Gynecological Therapeutic Devices"
section_number: "884.5970"
section_subject: "Clitoral engorgement device."
cfr_reference: "21 CFR 884.5970"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.”