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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 K251449
Device Name BrainsWay Deep TMS System
Applicant
Brainsway , Ltd.
16 Hartom St. (Bynat Bldg)
Har Hotzvim
Jerusalem,  IL 9777518
Applicant Contact Colleen Hanlon
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
18 Hata'As St.
Kfar Saba,  IL 4442518
Correspondent Contact Ahava Stein
Regulation Number882.5805
Classification Product Code
OBP  
Date Received05/09/2025
Decision Date 09/13/2025
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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