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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 K161241
Device Name e-fix E35/E36
Applicant
Alber GmbH
Vor Dem Weissen Stein 21
Albstadt,  DE 72461
Applicant Contact MICHAEL VENT
Correspondent
Beo Medconsulting Berlin GmbH
Helmholtzstr. 2-9
Berlin,  DE 10587
Correspondent Contact MICHAEL VENT
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/02/2016
Decision Date 10/05/2016
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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