| Device |
repetitive transcranial magnetic stimulator for treatment of major depressive disorder |
| Regulation Description |
Repetitive transcranial magnetic stimulation system. |
| Definition |
A transcranial magnetic stimulation system is a device that non-invasively delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the the patient's cerebral cortex to treat the symptoms of major depressive disorder without inducing seizure.Indicated for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above teh minimal effective dose and duration in the current episode. |
| 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 |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5805
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
