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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromagnetic Stimulator, Pain Relief
510(k) Number K250286
Device Name Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
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 Number882.5890
Classification Product Code
QPL  
Subsequent Product Code
IPF  
Date Received01/31/2025
Decision Date 07/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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