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 |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation 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 |