| Device |
transcranial magnetic stimulation system for obsessive-compulsive disorder |
| Regulation Description |
Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions. |
| Definition |
External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). |
| Physical State |
Device consists of an electromagnetic coil, a neurostimulator to generate the electrical stimulus for the coil, a cooling system, a positioning device, and software to control the device. |
| Technical Method |
Delivers brief duration, rapidly alternating, or pulsed, magnetic fields induce electrical currents in the brain that are directed at spatially discrete regions of the cerebral cortex |
| Target Area |
Cerebral cortex |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | QCI |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5802
|
|---|
| 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 |
