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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 K243961
Device Name Electrically Powered Wheelchair
Applicant
Kunshan Hi-Fortune Health Products Co., Ltd.
#625 Juxiang Rd., Zhangpu Town
Kunshan,  CN 215321
Applicant Contact Zhanli Tian
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ariel Xiang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/23/2024
Decision Date 02/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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