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FDA PRODUCT CODE · CLASS II

QAR — Thermal Vestibular Stimulator For Headache

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

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5893
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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