| Device |
stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief |
| Regulation Description |
Transcutaneous electrical nerve stimulator for pain relief. |
| Definition |
Nerve stimulation for relief of pain. |
| Physical State |
Electrical stimulation unit with leads and cutaneous electrodes |
| Technical Method |
Stimulation of nerves using electrical current applied to electrodes on a patient's skin |
| Target Area |
Electrodes are placed on the skin in proximity to the painful area |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | NYW |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5890
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
