← FDA Medical Device Classifications

Pressure Ulcer Management Tool

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

Authoritative
FDA Device Classification database
Machine
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