PAE

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

Device class

Class II (moderate risk)

Regulation

21 CFR 890.3450

Medical specialty

Physical Medicine

FDA 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.

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