QCF — Electrical Tongue Stimulator To Treat Motor Deficits Class II
FDA product code QCF covers "Electrical Tongue Stimulator To Treat Motor Deficits", a Class II medical device regulated under 21 CFR 882.5889. Submissions are reviewed by the Neurology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QCF
- Device Class
- Class II
- Regulation Number
- 882.5889
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.