Portable Neuromodulation Stimulator (PoNS)

Neuromuscular Tongue Stimulator To Treat Motor Deficits

Helius Medical, Inc.

The following data is part of a De Novo classification by Helius Medical, Inc. with the FDA for Portable Neuromodulation Stimulator (pons).

Pre-market Notification Details

DeNovo IDDEN200050
Device Name:Portable Neuromodulation Stimulator (PoNS)
ClassificationNeuromuscular Tongue Stimulator To Treat Motor Deficits
Applicant Helius Medical, Inc. 642 Newtown Yardley Road, Suite 100 Newtown,  PA  18940
ContactLawrence Picciano
Product CodeQCF  
CFR Regulation Number882.5889 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryNeurology
TypeDirect
Date Received2020-08-04
Decision Date2021-03-26
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00864288000431 DEN200050 000
00864288000462 DEN200050 000

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