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..
2
Total
1
Cleared
234d
Avg days
2021
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
233d avg (recent)
FDA 510(k) Cleared Electrical Tongue Stimulator To Treat Motor Deficits Devices (Product Code QCF)
2 devices
Cleared
May 13, 2026
Portable Neuromodulation Stimulator (PoNS)
Helius Medical, Inc.
Neurology
233d
Not Cleared
Mar 26, 2021
Portable Neuromodulation Stimulator (PoNS)
Helius Medical, Inc.
Neurology
234d
About Product Code QCF - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QCF since 2021, with 1 receiving FDA clearance (average review time: 234 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QCF Product Code
FDA review times for QCF submissions have been consistent, averaging 233 days recently vs 234 days historically.
QCF devices are reviewed by the Neurology panel. Browse all Neurology devices →