Product code QCF

Device name
Electrical Tongue Stimulator To Treat Motor Deficits
Medical specialty
Neurology
Device class
2
Regulation number
882.5889
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset