| 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 Rehabilitation 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 |
