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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device walker, mechanical, poly vinyl chloride (pvc)
Regulation Description Mechanical walker.
Definition This type of mechanical walker is a four-legged device with a poly vinyl chloride (pvc) frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.
Product CodeNXE
Regulation Number 890.3825
Device Class 1

Premarket Reviews

Device Problems
Bent 1
Break 1
Improper or incorrect procedure or method 1
Total Device Problems 3