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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pressure ulcer management tool
Regulation Description Pressure ulcer management tool.
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.
Product CodeQEF
Regulation Number 876.2100
Device Class 1

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