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 Maj
| Device Type ID | 3760 |
| Device Name | Transcranial Magnetic Stimulator |
| 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 Int |
| 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 Description | Repetitive Transcranial Magnetic Stimulation System. |
| 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 | 882.5805 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3760 |
| Device | Transcranial Magnetic Stimulator |
| Product Code | OBP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Repetitive Transcranial Magnetic Stimulation System. |
| CFR Regulation Number | 882.5805 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRAINSWAY LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAGSTIM COMPANY LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEURONETICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEURONETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEXSTIM PLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TELEEMG, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | The Magstim Company Limited | II | Feb-14-2019 |
| 2 | The Magstim Company Limited | II | Apr-11-2018 |