FDA product code QEF: Pressure Ulcer Management Tool
QEF is the FDA product code for pressure ulcer management tool. It is a Class I device, regulated under 21 CFR 876.2100 and reviewed by the Gastroenterology and Urology panel. Devices under QEF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a users decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.
Classification
| Field | Value |
|---|---|
| Device name | Pressure Ulcer Management Tool |
| Device class | Class I |
| Regulation | 21 CFR 876.2100 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for QEF devices
openFDA lists no recalls for product code QEF.
Frequently asked questions
What is FDA product code QEF?
QEF is the FDA product code for pressure ulcer management tool. It is a Class I device, regulated under 21 CFR 876.2100 and reviewed by the Gastroenterology and Urology panel.
What device class is QEF?
Class I, regulation 21 CFR 876.2100. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QEF
- Run a recall and safety report across every QEF manufacturer
- Watch product code QEF 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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