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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K192016
Device Name SMOOV O10
Applicant
Alber GmbH
Vor Dem Weißen Stein 21
Albstadt,  DE 72461
Applicant Contact Michael Vent
Correspondent
Alber GmbH
Vor Dem Weißen Stein 21
Albstadt,  DE 72461
Correspondent Contact Michael Vent
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/29/2019
Decision Date 05/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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