Product code QEF

Device name

Pressure Ulcer Management Tool

Medical specialty

Gastroenterology, Urology

Device class

1

Regulation number

876.2100

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset