SIG

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

Product code
SIG
Device name
Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)
Device class
Class 2
21 CFR
21 CFR 882.5802
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-06-03.

NumberDecision dateApplicantDevice nameSummary
K2604022026-06-03Wave NeuroscienceMeRT SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: SIG
Classification and pathway per current FDA publications. Data from openFDA (CC0).