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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 K012592
Device Name EASYTRAVEL
Applicant
Tzora Active Systems , Ltd.
Kibbutz Tzora,  IL 99803
Applicant Contact YOEL ETZIONI
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact MARK JOB
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/10/2001
Decision Date 10/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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