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PoNS 1.1

by Helius Medical, Inc 3 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00864288000462 UDI-DI Date20 Jun 2022ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PoNS
Generic Name
Balance therapy translingual electrical stimulation system
Model / Ref / Catalog
1.1, S1-001-02
Primary DI / UDI-DI
00864288000462
De Novo Number
FDA Product Code
QCF
GMDN Term
Balance therapy translingual electrical stimulation system
Device Class
Class II
Regulation Number
882.5889
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Balance therapy translingual electrical stimulation system

Cleared under the same submission (DEN200050)

Other devices from Helius Medical, Inc

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No