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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 K253707
Device Name Electric wheelchair (W1,W3)
Applicant
Shenzhen Zhimahuaerkai Technology Co., Ltd.
Rm. 602, Bldg. F1, Tcl Science Park, #1001 Zhongshan
Garden Rd., Shuguang Community, Xili St., Nanshan Distri
Shenzhen,  CN
Applicant Contact Xianwei Zhang
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 Received11/24/2025
Decision Date 02/24/2026
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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