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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K260094
Device Name Mobility Scooter (W3465, W3902 (S50 Carbon))
Applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
#196 Industry Rd., Hengdian Movie Zone
Dongyang,  CN
Applicant Contact Yolanda Ge
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3800
Classification Product Code
INI  
Date Received01/13/2026
Decision Date 08/10/2026
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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