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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 K163204
Device Name A08 Power wheelchair
Applicant
Kunshan Aoshida Electric Technology Co., Ltd.
# 65, Matang Rd.
Kunshan,  CN 215300
Applicant Contact Shen Wenhua
Correspondent
Irc China
16f-2(16a), # 462, Sec. 2, Chongde Rd., Beitun Dist.
Taichung,  TW 406
Correspondent Contact Junnata Chang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/15/2016
Decision Date 05/05/2017
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
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