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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography
Regulation Description Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components.
Definition Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality.
Product CodePAE
Regulation Number 890.3450
Device Class 2

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