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QCFClass II

Electrical Tongue Stimulator To Treat Motor Deficits

21 CFR 882.5889 / Neurology
FDA source (opens on fda.gov)

QCF is the FDA product code for Electrical Tongue Stimulator To Treat Motor Deficits, a class II device type, regulated under 21 CFR 882.5889. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QCF
Device name
Electrical Tongue Stimulator To Treat Motor Deficits
FDA 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.
Regulation
21 CFR 882.5889
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QCF

By decision year
2 clearances under product code QCF with a decision year between 2021 and 2026, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QCF by decision year
YearClearances
20211
20261

Applicants with the most clearances

Product code QCF
Applicants holding the most 510(k) clearances under product code QCF
ApplicantClearances
Helius Medical, Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code