QCF · Class II · 21 CFR 882.5889

FDA Product Code QCF: Electrical Tongue Stimulator To Treat Motor Deficits

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.

Leading manufacturers include Helius Medical, Inc..

1
Total
0
Cleared
234d
Avg days
2021
Since

FDA 510(k) Cleared Electrical Tongue Stimulator To Treat Motor Deficits Devices (Product Code QCF)

1 devices
1–1 of 1
Not Cleared Mar 26, 2021
Portable Neuromodulation Stimulator (PoNS)
DEN200050
Helius Medical, Inc.
Neurology · 234d

About Product Code QCF - Regulatory Context

QCF devices are reviewed by the Neurology panel. Browse all Neurology devices →