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510(k) DEN200050

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

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 26, 2021
Date Received
August 4, 2020
Clearance Type
Direct
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.

  • K253061 — Portable Neuromodulation Stimulator (PoNS) (May 13, 2026)

Other clearances for product code QCF

  • K253061 — Portable Neuromodulation Stimulator (PoNS) (May 13, 2026)