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510(k) K253061

Portable Neuromodulation Stimulator (PoNS) by Helius Medical, Inc. — Product Code QCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2026
Date Received
September 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrical Tongue Stimulator To Treat Motor Deficits
Device Class
Class II
Regulation Number
882.5889
Review Panel
NE
Submission Type

An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits.

Other clearances by Helius Medical, Inc.

  • DEN200050 — Portable Neuromodulation Stimulator (PoNS) (March 26, 2021)

Other clearances for product code QCF

  • DEN200050 — Portable Neuromodulation Stimulator (PoNS) (March 26, 2021)