| Device |
exercise equipment, powered, emg-triggered |
| Regulation Description |
Diagnostic electromyograph. |
| Definition |
To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education. |
| Physical State |
EMG sensor, plus other apparatus such as a DC motor, limb orthosis, and connecting cables through which tension is applied. |
| Technical Method |
EMG in affected area is sensed, processed, and used as an input to control a DC motor or other actuator that applies a force/torque to move an affected joint through range of motion. |
| Target Area |
Typically, such a device will be used on the upper extremity or possibily the lower extremity. |
| Regulation Medical Specialty |
Physical Medicine |
| Review Panel |
Physical Medicine |
|---|
| Product Code | OAL |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
890.1375
|
|---|
| 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 |
