section_subject: "Thermal vestibular stimulator for headache."
cfr_reference: "21 CFR 882.5893"
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. The thermal vestibular stimulator for headache is a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)The patient-contacting components of the device must be demonstrated to be biocompatible.
(2)Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
(3)The technical parameters of the device, including waveform outputs and temperature limits, must be identified.
(4)Cleaning validation of earpieces must be conducted.
(5)Software verification, validation, and hazard analysis must be performed.