510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260402Substantially Equivalent

MeRT System

Wave Neuroscience, Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260402 is the FDA 510(k) clearance record for MeRT System, a class II device, cleared for Wave Neuroscience on under FDA product code SIG (Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)). FDA's definition for product code SIG reads: "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...". FDA records list one 510(k) clearance for Wave Neuroscience. As of , FDA records show no recalls naming K260402.

Clearance record

Decision date
Received
(117 days to decision)
Product code
SIG Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)
Regulation
21 CFR 882.5802
Device class
Class II
Review panel
Neurology
Applicant
Wave Neuroscience 1601 Dove St., Newport Beach CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SIG

Trailing 12 months
1 clearance under product code SIG in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260