Definition: Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields That Are Externally Directed At Spatially Discrete Regions Of The Brain To Induce Electric Currents For T
| Device Type ID | 3764 |
| Device Name | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache |
| Physical State | The Device Includes A Magnetic Coil, Power Modules, Software, And User Interface. |
| Technical Method | Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields That Are Externally Directed At Spatially Discrete Regions Of The Brain To Induce Electric Currents In The Brain. |
| Target Area | Stimulation To The Head. |
| Regulation Description | Transcranial Magnetic Stimulator For Headache. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5808 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OKP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3764 |
| Device | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache |
| Product Code | OKP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Transcranial Magnetic Stimulator For Headache. |
| CFR Regulation Number | 882.5808 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ENEURA INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENEURA THERAPEUTICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |