# Pressure Ulcer Management Tool
> **Product code: QEF** · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.2100
## Classification
- **FDA Product Code:** QEF
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 876.2100
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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 user’s decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QEF)
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