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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 K041186
Device Name CADDY
Applicant
Afikim Electric Vehicles
Kibbutz Afikim,  IL 15148
Applicant Contact AVNER FISHBEIN
Correspondent
Afikim Electric Vehicles
Kibbutz Afikim,  IL 15148
Correspondent Contact AVNER FISHBEIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/06/2004
Decision Date 09/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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