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QCF

Electrical Tongue Stimulator To Treat Motor Deficits

Product code
QCF
Device name
Electrical Tongue Stimulator To Treat Motor Deficits
Device class
Class 2
21 CFR
21 CFR 882.5889
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-05-13.

NumberDecision dateApplicantDevice nameSummary
K2530612026-05-13Helius Medical, Inc.Portable Neuromodulation Stimulator (PoNS)PDF

1 summaries are archived here for direct download.

Official FDA classification page: QCF
Classification and pathway per current FDA publications. Data from openFDA (CC0).