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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 K142162
Device Name MERITS TRANSFORMER POWER SCOOTER, S941
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
NO.18 JINGKE RD.
NANTUN DIST
TAICHUNG,  TW 40852
Applicant Contact VINCENT CHEN
Correspondent
MERITS HEALTH PRODUCTS CO., LTD.
NO.18 JINGKE RD.
NANTUN DIST
TAICHUNG,  TW 40852
Correspondent Contact VINCENT CHEN
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/06/2014
Decision Date 05/01/2015
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
Recalls CDRH Recalls
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