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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 K241723
Device Name Electric wheelchair (W3902)
Applicant
Zhejiang Richall Medical Technology Co., Ltd.
# 353 Baozhang Ave., Xianhua St.
Pujiang County
Jinhua City,  CN
Applicant Contact Dragon Long
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 Received06/14/2024
Decision Date 09/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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