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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 K211647
Device Name HP358EA Electrically Powered Wheelchair
Applicant
Kunshan Hi-Fortune Health Products Co., Ltd.
#625 Juxiang Rd., Zhangpu Town
Kunshan,  CN 215321
Applicant Contact Jianjiang Fan
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 Lujiazui E. Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/28/2021
Decision Date 01/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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