Product Classification

• 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 Code: PAE
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); 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

Recognized Consensus Standard

• 17-20 IEC 60601-2-40 Third edition 2024-12
  Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

Third Party Review

Not Third Party Eligible