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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 K253952
Device Name Power Wheelchair (OS-R-M01S)
Applicant
Beijing OrionStar Technology Co., Ltd.
Rm. 1201-7, 12th Floor, Bldg. 1, Yard 60
Heping W. Rd., Shijingshan District
Beijing,  CN
Applicant Contact Shengnan Fang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Ariel Xiang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/10/2025
Decision Date 04/07/2026
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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