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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name thermal vestibular stimulator for headache
De Novo Number DEN170023
Device Name ThermoNeuroModulation Device, TNM Device
Scion NeuroStim, LLC
3105 cone manor lane
raleigh,  NC  27613 -6606
Contact robert black
Regulation Number882.5893
Classification Product Code
Date Received04/17/2017
Decision Date 03/26/2018
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct