DeviceClearance

Product code QEF— Gastroenterology, Urology

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Classification name
Pressure Ulcer Management Tool
Device class
Class 1
Regulation
21 CFR 876.2100
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QEF under 21 CFR 876.2100, via openFDA

Market context for product code QEF

FDA has cleared 1 device under product code QEF, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QEF

Recent clearances under product code QEF

Data sourced from openFDA. This site is unofficial and independent of the FDA.