DeviceClearance

Product code QAR— Neurology

ThermoNeuroModulation Device, TNM Device

Classification name
Thermal Vestibular Stimulator For Headache
Device class
Class 2
Regulation
21 CFR 882.5893
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.”

— U.S. Food and Drug Administration, device classification record for product code QAR under 21 CFR 882.5893, via openFDA

Market context for product code QAR

FDA has cleared 1 device under product code QAR, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QAR

Recent clearances under product code QAR

Data sourced from openFDA. This site is unofficial and independent of the FDA.