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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 electrical tongue stimulator to treat motor deficits
De Novo Number DEN200050
Device Name Portable Neuromodulation Stimulator (PoNS)
Requester
helius medical, inc.
642 newtown yardley rd. suite 100
newton,  PA  18940
Contact lawrence picciano
Regulation Number882.5889
Classification Product Code
QCF  
Date Received08/04/2020
Decision Date 03/26/2021
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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