MeRT System is an AI-enabled medical device from Wave Neuroscience that the U.S. FDA cleared through 510(k) K260402 on June 3, 2026. Its lead review panel is Neurology and its primary product code is SIG (Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)).
See also FDA-cleared AI neurology devices in 2026, all FDA AI clearances in 2026, top neurology AI devices.
Key facts
| Submission number | K260402 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Wave Neuroscience |
| Lead review panel | Neurology |
| Primary product code | SIG — Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd) |
| Applicant (openFDA) | Wave Neuroscience |
| Applicant location | Newport Beach, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 882.5802 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. MeRT System went through this pathway (K260402).
openFDA lists it as a Class 2 device under 21 CFR 882.5802. Class II devices are moderate risk and are subject to general and special controls.
Product code SIG covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Wave Neuroscience has 1 AI-enabled device on the list, and the Neurology panel accounts for 73 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.