FDA product code QAK: Non-Invasive Vagus Nerve Stimulator For Migraine Headache
QAK is the FDA product code for non-invasive vagus nerve stimulator for migraine headache. It is a Class II device, regulated under 21 CFR 882.5892 and reviewed by the Neurology panel. Devices under QAK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat migraine headache.
Classification
| Field | Value |
|---|---|
| Device name | Non-Invasive Vagus Nerve Stimulator For Migraine Headache |
| Device class | Class II |
| Regulation | 21 CFR 882.5892 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for QAK devices
openFDA lists no recalls for product code QAK.
Frequently asked questions
What is FDA product code QAK?
QAK is the FDA product code for non-invasive vagus nerve stimulator for migraine headache. It is a Class II device, regulated under 21 CFR 882.5892 and reviewed by the Neurology panel.
What device class is QAK?
Class II, regulation 21 CFR 882.5892. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QAK
- Run a recall and safety report across every QAK manufacturer
- Watch product code QAK 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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