Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter HPart 882Subpart F → §882.5893


Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices


§882.5893   Thermal vestibular stimulator for headache.

(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.

(6) Labeling must include the following:

(i) Information on how the device operates and the typical sensations experienced during treatment;

(ii) A detailed summary of the device's technical parameters; and

(iii) Instructions for maintenance and cleaning of the device.

[83 FR 52973, Oct. 19, 2018]

Need assistance?