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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 K241518
Device Name Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
Applicant
The Magstim Company Limited
Spring Gardens
Whitland
Carmarthenshire,  GB SA34 0HR
Applicant Contact Daniel Gregory
Correspondent
The Magstim Company Limited
Spring Gardens
Whitland
Carmarthenshire,  GB SA34 0HR
Correspondent Contact Daniel Gregory
Regulation Number882.5805
Classification Product Code
OBP  
Subsequent Product Code
QCI  
Date Received05/29/2024
Decision Date 08/30/2024
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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