| Device |
electroencephalography (eeg)-driven upper extremity powered exerciser |
| Regulation Description |
Electroencephalography (EEG)-driven upper extremity powered exerciser. |
| Definition |
An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain. |
| Physical State |
Device includes components for recording EEG signals, moving the hand, and controlling the program. |
| Technical Method |
The device relies on signals recorded through EEG to encode movement intention and pairs that with movement of the hand. |
| Target Area |
Upper limb rehabilitation |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Physical Medicine |
|---|
| Product Code | QOL |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
890.5420
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
