| Device |
stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief |
| Regulation Description |
Transcutaneous electrical nerve stimulator for pain relief. |
| Definition |
Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). |
| Physical State |
Electrical stimulation unit with leads and cutaneous electrodes. |
| Technical Method |
Applies an electrical current through electrodes on a patient's skin. |
| Target Area |
Electrodes are placed on the skin to stimulate nerves in proximity to the painful joint. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | OCF |
|---|
| 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 |
