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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
510(k) Number K243459
Device Name Ultimate rTMS for OCD (M-series)
Applicant
Brain Ultimate, Inc.
5910 Shiloh Rd. E.
Alpharetta,  GA  30005
Applicant Contact Frank Ge
Correspondent
Makromed, Inc.
88 Stiles Rd.
Salem,  NH  03079
Correspondent Contact Barry Ashar
Regulation Number882.5802
Classification Product Code
QCI  
Date Received11/08/2024
Decision Date 04/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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