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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 Stimulator
510(k) Number K261228
Device Name QuickVision Ultimate rTMS
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 Number882.5805
Classification Product Code
OBP  
Subsequent Product Code
SGE  
Date Received04/15/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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