section_subject: "Vibrator for climax control of premature ejaculation."
cfr_reference: "21 CFR 876.5025"
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 vibrator for climax control of premature ejaculation is used for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)The labeling must include specific instructions regarding the proper placement and use of the device.
(2)The portions of the device that contact the patient must be demonstrated to be biocompatible.
(3)Appropriate analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety, and thermal safety of the device.
(4)Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.