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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 K122357
Device Name MERITS MODEL P322FWD POWERED WHEELCHAIR
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
NO.18 JINGKE RD.
NANTUN DIST
TAICHUNG,  TW 40852
Applicant Contact STEVE CHAO
Correspondent
MERITS HEALTH PRODUCTS CO., LTD.
NO.18 JINGKE RD.
NANTUN DIST
TAICHUNG,  TW 40852
Correspondent Contact STEVE CHAO
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/03/2012
Decision Date 01/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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