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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 K142027
Device Name 888 WNLE POWERED WHEELCHAIR
Applicant
Pihsiang Machinery Mfg. Co., Ltd.
21184 Figueroa St.
Carson,  CA  90745
Applicant Contact DAVID LIN
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plz., Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/25/2014
Decision Date 10/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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