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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 K253789
Device Name Electric wheelchair
Applicant
Zhejiang Yikang Medical Technology Co., Ltd.
Bldg. 1, # 2 Shan Yan Rd., Huzhen Town
Jinyun County
Lishui,  CN 321404
Applicant Contact David Shi
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/28/2025
Decision Date 02/25/2026
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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