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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Upper extremity prosthesis composed of plastic and metal materials with electrodes and circuitry.
Technical Method Receives multiple EMG inputs from the user which is transduced into multiple dimensional powered joint movements.
Target Area Residual portion of upper extremity limb or an absent upper extremity limb.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodePAE
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.3450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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