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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 K201855
Device Name Electrically Powered Wheelchair -Model HP358E
Applicant
Kunshan Hi-Fortune Health Products Co., Ltd.
No. 625, Juxiang Road, Zhangpu Town
Kunshan,  CN 215321
Applicant Contact Jianjiang Fan
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM. 608, No.738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/06/2020
Decision Date 09/28/2021
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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