| Device |
electromagnetic stimulator, pain relief |
| Regulation Description |
Transcutaneous electrical nerve stimulator for pain relief. |
| Definition |
Intended to apply a magnetic-field induced electrical current to treat pain. |
| Physical State |
The device comes in a variety of shapes and sizes. It generally includes a magnetic stimulator, a stimulation coil, a cooling system, and other accessories. |
| Technical Method |
This device uses a magnetic coil to produce a time-varying magnetic field, which induces a secondary electric field in the targeted tissues which, in turn, non-invasively stimulates peripheral nerves and provides chronic nerve pain relief. |
| Target Area |
This device generally targets peripheral nerves in lower and/or upper extremities and low back. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Physical Medicine |
|---|
| Product Code | QPL |
|---|
| Premarket Review |
Neuromodulation and Physical Medicine Devices
(DHT5B)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5890
|
|---|
| 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 |
