Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)
510(k) Number K260402
Device Name MeRT System
Applicant
Wave Neuroscience
1601 Dove St.
Suite 205
Newport Beach,  CA  92660
Applicant Contact Leslie Prichep
Correspondent
Wave Neuroscience
1601 Dove St.
Suite 205
Newport Beach,  CA  92660
Correspondent Contact Leslie Prichep
Regulation Number882.5802
Classification Product Code
SIG  
Date Received02/06/2026
Decision Date 06/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02990793
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-