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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device orthosis, corrective shoe
Regulation Description Limb orthosis.
Product CodeKNP
Regulation Number 890.3475
Device Class 1

Device Problems
Adverse Event Without Identified Device or Use Problem 17
Insufficient Information 5
Patient Device Interaction Problem 4
Naturally Worn 3
Device Contaminated during manufacture or shipping 2
Mechanical Problem 1
Inadequacy of Device Shape and/or Size 1
Break 1
Unstable 1
Hole In Material 1
Device Slipped 1
Sharp Edges 1
Total Device Problems 38


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