Cleared Traditional

K260402 - MeRT System

K260402 · Wave Neuroscience · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
117d
Days
-
Risk

K260402 is an FDA 510(k) clearance for the MeRT System.

Submitted by Wave Neuroscience (Newport Beach, US). The FDA issued a Cleared decision on June 3, 2026 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wave Neuroscience devices

FDA 510(k) Submission Details - K260402

510(k) Number K260402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2026
Decision Date June 03, 2026
Days to Decision 117 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

SIG Device Classification - Class ,

Product Code SIG
Device Class -

Clinical Evidence

ClinicalTrials.gov
NCT02990793 Completed Interventional Industry-sponsored

Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder

A Prospective, Double Blind, Randomized, Sham-Controlled, Clinical Trial to Evaluate The Safety And Efficacy Of Biometrics-Guided Magnetic EEG Resonance Therapy (MeRT) Treatment Of Post-Traumatic Stress Disorder

158
Patients (actual)
8
Sites
Treatment
Purpose
Triple
Masking
Condition studied PostTraumatic Stress Disorder; Traumatic Brain Injury; Postconcussive Symptoms
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Kenneth Ramos, MD,PhD
Sponsor Wave Neuroscience (industry)
Started 2022-04-04 → Primary completion 2025-09-18 → Completed 2025-11-04
Primary outcome
Change in PTSD Symptoms
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov