QAKClass II

Non-Invasive Vagus Nerve Stimulator For Migraine Headache

21 CFR 882.5892 / Neurology

QAK is the FDA product code for Non-Invasive Vagus Nerve Stimulator For Migraine Headache, a class II device type, regulated under 21 CFR 882.5892. FDA's definition for this code reads: "The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat migraine headache". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QAK
Device name: Non-Invasive Vagus Nerve Stimulator For Migraine Headache
FDA definition: The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat migraine headache.
Regulation: 21 CFR 882.5892
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Electrocore, Inc.

Recent clearances

Product code QAK

FDA records hold no clearances under product code QAK.

Recent recalls

Product code QAK

FDA records show no recalls under product code QAK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)