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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 neuromuscular tongue stimulator to treat motor deficits
De Novo Number DEN200050
Device Name Portable Neuromodulation Stimulator (PoNS)
Helius Medical, Inc.
642 newtown yardley road, suite 100
newtown,  PA  18940
Contact lawrence picciano
Regulation Number882.5889
Classification Product Code
Date Received08/04/2020
Decision Date 03/26/2021
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct