FDA product code QAR: Thermal Vestibular Stimulator For Headache
QAR is the FDA product code for thermal vestibular stimulator for headache. It is a Class II device, regulated under 21 CFR 882.5893 and reviewed by the Neurology panel. Devices under QAR reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.
Classification
| Field | Value |
|---|---|
| Device name | Thermal Vestibular Stimulator For Headache |
| Device class | Class II |
| Regulation | 21 CFR 882.5893 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for QAR devices
openFDA lists no recalls for product code QAR.
Frequently asked questions
What is FDA product code QAR?
QAR is the FDA product code for thermal vestibular stimulator for headache. It is a Class II device, regulated under 21 CFR 882.5893 and reviewed by the Neurology panel.
What device class is QAR?
Class II, regulation 21 CFR 882.5893. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QAR
- Run a recall and safety report across every QAR manufacturer
- Watch product code QAR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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