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FDA product code QAR

Thermal Vestibular Stimulator For Headache

NeurologyClass 221 CFR 882.5893
US regulatory classifications
US Product Code (FDA)
QAR
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5893
Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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

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About this record

Thermal Vestibular Stimulator For Headache is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.