QEF

Pressure Ulcer Management Tool

Product code

QEF

Device name

Pressure Ulcer Management Tool

Device class

Class 1

21 CFR

21 CFR 876.2100

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).