Product code QCF— Neurology
Portable Neuromodulation Stimulator (PoNS)
- Classification name
- Electrical Tongue Stimulator To Treat Motor Deficits
- Device class
- Class 2
- Regulation
- 21 CFR 882.5889
- Advisory panel
- Neurology
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QCF
FDA has cleared devices under product code QCF between 2021 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2021
Top applicants under product code QCF
Recent clearances under product code QCF
Data sourced from openFDA. This site is unofficial and independent of the FDA.