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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powered exoskeleton
Regulation Description Powered lower extremity exoskeleton.
Definition A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis used for medical purposes that is placed over a person's paralyzed or weakened limbs for the purpose of providing ambulation.
Product CodePHL
Regulation Number 890.3480
Device Class 2

Device Problems
Fracture 5
Detachment of device or device component 5
Device handling issue 2
Crack 1
Human-Device Interface Issue 1
Unintended movement 1
Misassembled by Users 1
Total Device Problems 16

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