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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 K011707
Device Name TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
Applicant
MERITS MEDICAL INDUSTRIES CO., LTD.
P.O.BOX 150356
CAPE CORAL,  FL  33915
Applicant Contact WINSTON ANDERSON
Correspondent
MERITS MEDICAL INDUSTRIES CO., LTD.
P.O.BOX 150356
CAPE CORAL,  FL  33915
Correspondent Contact WINSTON ANDERSON
Regulation Number890.3800
Classification Product Code
INI  
Date Received06/04/2001
Decision Date 08/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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