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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 K262213
Device Name Power Mobility Scooter (MA03)
Applicant
Nanjing Mijo Technology Co., Ltd.
Bldg. A3-2, Yongning Intelligent Manufacturing Industrial Pa
#77 Hupo Rd.
Nanjing,  CN
Applicant Contact Leo Zhang
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Andrew Wang
Regulation Number890.3800
Classification Product Code
INI  
Date Received06/30/2026
Decision Date 09/29/2026
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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