Devices · Wave Neuroscience

MeRT System

Wave Neuroscience is listed for MeRT System (K260402). The FDA list gives June 3, 2026 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SIG as “Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)”: 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). openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260402

Official FDA database record

Date of final decision

June 3, 2026

Company on the FDA list

Wave Neuroscience

Lead panel

Neurology

Primary product code

SIG

openFDA device name for the code

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

Device class

2

Regulation number

882.5802

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary