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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 K262054
Device Name Electric Wheelchair
Applicant
Yongkang Joymax Medical Technology Co., Ltd.
1st Floor Bldg. 1 And 3rd Floor Bldg. 3, #88 Yuegui S. Rd.,
Yongkang,  CN
Applicant Contact Sufiya Dong
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/18/2026
Decision Date 09/16/2026
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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