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Electrical Tongue Stimulator To Treat Motor Deficits

FDA product code QCF · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.5889
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-05-13 – 2026-05-13

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.

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