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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 K260937
Device Name Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)
Applicant
Shanghai Waylong Intelligent Technology Co.,Ltd
2-3/F, Bldg. 3, # 238 Huida Rd., Zhangyan Town, Jinshan Dist
Shanghai,  CN
Applicant Contact Jin Chunxiang
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 Received03/20/2026
Decision Date 06/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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