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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K160909
Device Name ATTO Mobility Scooter
Applicant
Moving Life, Ltd.
Haofe 2
Kadima,  IL 6092000
Applicant Contact Nino A. Ransenberg
Correspondent
Igor Naroditsky, Medical Device Certification, LLC
Emeq Hashalom 26/2
Yoqneam Illit,  IL 20692
Correspondent Contact Igor Naroditsky
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/01/2016
Decision Date 10/04/2016
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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