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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 K260335
Device Name Electric Wheelchair (S500-6)
Applicant
Zhongshan Sulenz Intelligent Technology Co., Ltd.
One Of 2f B Area, A4 Bldg., # 17 Shabian Rd.
Shabian Industrial Zone, Torch Development Zone
Zhongshan,  CN
Applicant Contact Luo Weiping
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Andrew Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/02/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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