FDA product code QFD: Tens For Sinus Pain
QFD is the FDA product code for tens for sinus pain. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. Devices under QFD reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Electrical stimulation to relieve pain
Classification
| Field | Value |
|---|---|
| Device name | Tens For Sinus Pain |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for QFD devices
openFDA lists no recalls for product code QFD.
Frequently asked questions
What is FDA product code QFD?
QFD is the FDA product code for tens for sinus pain. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is QFD?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QFD
- Run a recall and safety report across every QFD manufacturer
- Watch product code QFD 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.