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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 K253936
Device Name Power Mobility Scooter (MJMA01, MJMA02)
Applicant
Nanjing Mijo Technology Co., Ltd.
2nd Floor, Bldg. A3, Hongfeng Science And Technology Park
Nanjing Economic And Technological Development Zone
Nanjing,  CN
Applicant Contact Leo Zhang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Luna Hu
Regulation Number890.3800
Classification Product Code
INI  
Date Received12/09/2025
Decision Date 03/12/2026
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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