Portable Neuromodulation Stimulator (PoNS)— 510(k) DEN200050

Unknown

Helius Medical, Inc.

FDA 510(k) clearance DEN200050 for Portable Neuromodulation Stimulator (PoNS), Unknown on 2021-03-26. Applicant: Helius Medical, Inc..

Clearance details

Applicant: Helius Medical, Inc.
Product code: Code QCF
Advisory panel: Neurology
Date received: 2020-08-04
Decision date: 2021-03-26
Decision: Unknown
Clearance type: Direct
Location: Newton, PA, US

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