Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart C — Monitoring Devices](/submissions/GU/subpart-c%E2%80%94monitoring-devices) → [21 CFR 876.2100](/submissions/GU/subpart-c%E2%80%94monitoring-devices/876.2100) → QEF — Pressure Ulcer Management Tool

# QEF · Pressure Ulcer Management Tool

_Gastroenterology, Urology · 21 CFR 876.2100 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/QEF

## Overview

- **Product Code:** QEF
- **Device Name:** Pressure Ulcer Management Tool
- **Regulation:** [21 CFR 876.2100](/submissions/GU/subpart-c%E2%80%94monitoring-devices/876.2100)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 876.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN170021](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/QEF/DEN170021.md) | SEM Scanner (Model 200) | Bruin Biometrics, LLC | Dec 20, 2018 | DENG |

## Top Applicants

- Bruin Biometrics, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/QEF](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/QEF)

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