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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 K191179
Device Name Myo Plus
Applicant
Otto Bock Healthcare Products GmbH
Brehmstrabe 16
1110 Wien
Vienna,  AT
Applicant Contact Rene Urtz
Correspondent
Otto Bock Healthcare Products GmbH
Brehmstrabe 16
1110 Wien
Vienna,  AT
Correspondent Contact Rene Urtz
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received05/02/2019
Decision Date 09/04/2019
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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