SIG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)

Device class

Class II (moderate risk)

Regulation

21 CFR 882.5802

Medical specialty

Neurology

FDA 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 in brain areas outside cerebral cortex (e.g., cerebellum).

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