QCF — Electrical Tongue Stimulator To Treat Motor Deficits Class II

FDA Device Classification

Classification Details

Product Code: QCF
Device Class: Class II
Regulation Number: 882.5889
Submission Type
Review Panel: NE
Medical Specialty: Neurology
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K253061	helius medical	Portable Neuromodulation Stimulator (PoNS)	May 13, 2026
DEN200050	helius medical	Portable Neuromodulation Stimulator (PoNS)	March 26, 2021