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

Name: FDA 510(k) clearance DEN200050
Creator: U.S. Food and Drug Administration
Published: 2021-03-26

Unknown

Helius Medical, Inc.

FDA 510(k) clearance DEN200050 for Portable Neuromodulation Stimulator (PoNS), Unknown on 2021-03-26. Applicant: Helius Medical, Inc.. Device class: 2.

Clearance details

Applicant: Helius Medical, Inc.
Product code: Code QCF
Device class: Class 2
Regulation: 21 CFR 882.5889
Advisory panel: Neurology
Date received: 2020-08-04
Decision date: 2021-03-26
Decision: Unknown
Clearance type: Direct
Location: Newton, PA, US

View on FDA.gov ↗

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