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U.S. Department of Health and Human Services

Product Classification
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Device transcranial magnetic stimulator
Regulation Description Repetitive transcranial magnetic stimulation system.
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 major depressive disorder.
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 interface, control various subsystems.
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 Medical Specialty Neurology
Review Panel Neurology
Product CodeOBP
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5805
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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