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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 K254012
Device Name Electric Wheelchair (E201)
Applicant
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Bldg. A4, #128 Jiangjun Ave.
Jiangning District
Nanjing,  CN
Applicant Contact James Gu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/15/2025
Decision Date 03/24/2026
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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