QAK — Non-Invasive Vagus Nerve Stimulator For Migraine Headache Class II

FDA Device Classification

FDA product code QAK covers "Non-Invasive Vagus Nerve Stimulator For Migraine Headache", a Class II medical device regulated under 21 CFR 882.5892. Submissions are reviewed by the Neurology panel.

Classification Details

Product Code
QAK
Device Class
Class II
Regulation Number
882.5892
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat migraine headache.