QCF
- Product code
- QCF
- Device name
- Electrical Tongue Stimulator To Treat Motor Deficits
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5889
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K253061 | 2026-05-13 | Helius Medical, Inc. | Portable Neuromodulation Stimulator (PoNS) summary |
Official FDA classification page: QCF
Classification and pathway per current FDA publications. Data from openFDA (CC0).