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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 K252428
Device Name Electric Wheelchair (Model P2)
Applicant
Superpi Robot Co., Ltd.
Rm. N901, 9th Floor, Yungu Fudi Center, #181 Jingda Rd.
Hangzhou,  CN 310030
Applicant Contact Xuan Li
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/01/2025
Decision Date 09/18/2025
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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