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U.S. Department of Health and Human Services

Product Classification

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Device transcranial magnetic stimulator for the treatment of migraine headache
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 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 Medical Specialty Neurology
Review Panel Neurology
Product CodeOKP
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 882.5808
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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