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Portable Neuromodulation Stimulator (PoNS)

by Helius Medical, Inc 2 variants

De Novo DEN200050

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN200050 Date26 Mar 2021DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
QCF
FDA applicant
Helius Medical, Inc.
Device Class
Class II
Regulation
21 CFR Part 882.5889
Advisory Committee
Neurology
FDA Decision
DENG De Novo granted

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