FDA product code QNU: Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
QNU is the FDA product code for transcutaneous electrical nerve stimulator for the relief of congestion. It is a Class II device, regulated under 21 CFR 874.6000 and reviewed by the Ear, Nose and Throat panel. Devices under QNU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.
Classification
| Field | Value |
|---|---|
| Device name | Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion |
| Device class | Class II |
| Regulation | 21 CFR 874.6000 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Recalls for QNU devices
openFDA lists no recalls for product code QNU.
Frequently asked questions
What is FDA product code QNU?
QNU is the FDA product code for transcutaneous electrical nerve stimulator for the relief of congestion. It is a Class II device, regulated under 21 CFR 874.6000 and reviewed by the Ear, Nose and Throat panel.
What device class is QNU?
Class II, regulation 21 CFR 874.6000. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QNU
- Run a recall and safety report across every QNU manufacturer
- Watch product code QNU 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times