QAR

Thermal Vestibular Stimulator For Headache

Product code

QAR

Device name

Thermal Vestibular Stimulator For Headache

Device class

Class 2

21 CFR

21 CFR 882.5893

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.

Definition text from the FDA device classification database (U.S. federal government work, public domain).