| Device |
transcranial magnetic stimulator |
| Regulation Description |
Repetitive transcranial magnetic stimulation system. |
| Definition |
A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder. |
| Physical State |
Hardware (a treatment chair and head support, a console and gantry), a touch screen graphic user interface (GUI), system processor and power modules, a magnetic coil (Coil) and gantry, and Coil interface electronics) and software (to provide user interface, control various subsystems. |
| Technical Method |
A device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex. |
| Target Area |
Cerebral cortex |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | OBP |
|---|
| Premarket Review |
Neuromodulation and Rehabilitation Devices
(DHT5B)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5805
|
|---|
| 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 |
|
|
