Definition: To Provide Guidance For The Positioning And Orientation Of A Transcranial Magnetic Stimulation (TMS) System Coil Under The Supervision Of A Tracking System.
| Device Type ID | 3810 |
| Device Name | Electromechanical Arm For A Transcranial Magnetic Stimulation System |
| Physical State | A Mechanical Or Electromechanical Arm With Or Without A Cart, A Tracking System, Software, 3D Camera, Coil Adoption Kit With Or Without Its Mechanical Adaptor And A Contact Sensor. |
| Technical Method | A Tracking System Measures The Position And Orientation Of The Patient’s Head And The Software Uses The Measurements Provided By The Tracking System To Move The Robotic Arm And Position The Coil. A Contact Sensor Allows The Software To Measure Amount |
| Target Area | Head |
| Regulation Description | Repetitive Transcranial Magnetic Stimulation System. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5805 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QFF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |