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U.S. Department of Health and Human Services

Product Classification

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Device transcranial magnetic stimulation system for obsessive-compulsive disorder
Regulation Description Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Definition External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).
Physical State Device consists of an electromagnetic coil, a neurostimulator to generate the electrical stimulus for the coil, a cooling system, a positioning device, and software to control the device.
Technical Method Delivers brief duration, rapidly alternating, or pulsed, magnetic fields induce electrical currents in the brain that are directed at spatially discrete regions of the cerebral cortex
Target Area Cerebral cortex
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQCI
Premarket Review Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5802
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible