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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 K241588
Device Name Electric Wheelchair (KR8803)
Applicant
Zhejiang Kairui Medical Device Co., Ltd.
#85, Dengyun Rd.
Tangxia
Ruian,  CN 325200
Applicant Contact Jinfeng Ning
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Jinfeng Ning
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/03/2024
Decision Date 11/25/2024
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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