510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QARClass II

Thermal Vestibular Stimulator For Headache

21 CFR 882.5893 / Neurology
FDA source (opens on fda.gov)

QAR is the FDA product code for Thermal Vestibular Stimulator For Headache, a class II device type, regulated under 21 CFR 882.5893. FDA's definition for this code reads: "The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QAR
Device name
Thermal Vestibular Stimulator For Headache
FDA definition
The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.
Regulation
21 CFR 882.5893
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
1
Ingested recalls
0

Clearances, product code QAR

By decision year
1 clearance under product code QAR with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QAR by decision year
YearClearances
20181

Applicants with the most clearances

Product code QAR
Applicants holding the most 510(k) clearances under product code QAR
ApplicantClearances
Scion Neurostim, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QAR.