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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K253256
Device Name myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
Applicant
Otto Bock Healthcare Products GmbH
Brehmstrasse 16
Vienna,  AT 1110
Applicant Contact Reinhard Wolkerstorfer
Correspondent
Otto Bock Healthcare Products GmbH
Brehmstrasse 16
Vienna,  AT 1110
Correspondent Contact Rene Urtz
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received09/29/2025
Decision Date 04/22/2026
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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