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PoNS M1-001

by Bioness Medical, Inc.

Listed FDA GUDID listing, no authorization on record

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 Number00810188050755 UDI-DI Date10 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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 electrode array
Model / Reference
M1-001
Primary DI / UDI-DI
00810188050755
De Novo Number
FDA Product Code
QCF
GMDN Term
Balance therapy translingual electrical stimulation system electrode array
Device Class
Class II
Regulation Number
882.5889
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (DEN200050)

Other devices from Bioness Medical, Inc.

See all devices from Bioness Medical, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Expiration 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
  • Manufacturing Date: No