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 Cerebra
| Device Type ID | 3807 |
| Device Name | Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5802 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QCI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3807 |
| Device | Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
| Product Code | QCI |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 882.5802 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRAINSWAY LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |