| Device |
transcranial magnetic stimulator for the treatment of migraine headache |
| Regulation Description |
Transcranial magnetic stimulator for headache. |
| Definition |
Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache. |
| Physical State |
The device includes a magnetic coil, power modules, software, and user interface. |
| Technical Method |
Delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents in the brain. |
| Target Area |
Stimulation to the head. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | OKP |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5808
|
|---|
| 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 |
