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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K253301
Device Name BraiN20® (BraiN20)
Applicant
Time IS Brain, S.L.
Carretera De Canyet S/N
Badalona,  ES 08916
Applicant Contact Montserrat Gutiérrez de Dios
Correspondent
Time IS Brain, S.L.
Carretera De Canyet S/N
Badalona,  ES 08916
Correspondent Contact Montserrat Gutiérrez de Dios
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GXY   IKN  
Date Received09/29/2025
Decision Date 06/27/2026
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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