510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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DEN170023Unknown

ThermoNeuroModulation Device, TNM Device

Scion Neurostim, LLC, Raleigh NC / Direct, Unknown
FDA source (opens on fda.gov)

DEN170023 is the FDA 510(k) clearance record for ThermoNeuroModulation Device, TNM Device, a class II device, cleared for Scion Neurostim, LLC on under FDA product code QAR (Thermal Vestibular Stimulator For Headache). FDA's definition for product code QAR reads: "The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache". FDA records list one 510(k) clearance for Scion Neurostim, LLC. As of , FDA records show no recalls naming DEN170023.

Clearance record

Decision date
Received
(343 days to decision)
Product code
QAR Thermal Vestibular Stimulator For Headache
Regulation
21 CFR 882.5893
Device class
Class II
Review panel
Neurology
Applicant
Scion Neurostim, LLC 3105 Cone Manor Ln., Raleigh NC
Third party review
No

Clearances, product code QAR

Trailing 12 months

FDA records hold no clearances under product code QAR in the trailing twelve months.

FDA records show no clearances under product code QAR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QAR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260