FDA product code QCF: Electrical Tongue Stimulator To Treat Motor Deficits
QCF is the FDA product code for electrical tongue stimulator to treat motor deficits. It is a Class II device, regulated under 21 CFR 882.5889 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under QCF, 1 in the last five years. The average 510(k) review took 233 days (median 233); 233 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Electrical Tongue Stimulator To Treat Motor Deficits |
| Device class | Class II |
| Regulation | 21 CFR 882.5889 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QCF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 233 |
Compare with all 510(k) review times · Search every QCF clearance
Top QCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helius Medical, Inc. | 1 | 2026-05-13 |
Most recent QCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253061 | Helius Medical, Inc. | Portable Neuromodulation Stimulator (PoNS) | 2026-05-13 | 233 |
Recalls for QCF devices
openFDA lists no recalls for product code QCF.
Frequently asked questions
What is FDA product code QCF?
QCF is the FDA product code for electrical tongue stimulator to treat motor deficits. It is a Class II device, regulated under 21 CFR 882.5889 and reviewed by the Neurology panel.
What device class is QCF?
Class II, regulation 21 CFR 882.5889. Typical premarket route: 510(k).
How long does a 510(k) take for product code QCF?
Across 1 cleared submissions the average was 233 days from receipt to decision (median 233).
Which companies have the most QCF clearances?
Helius Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QCF
- Run a recall and safety report across every QCF manufacturer
- Watch product code QCF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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