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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 K232783
Device Name Power wheelchair (Model: JMPW-01W)
Applicant
Jiangsu Jumao x-Care Medical Equipment Co.,Ltd
No.36 Danyan Road
Danyang,  CN
Applicant Contact Weixia Shi
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/11/2023
Decision Date 01/19/2024
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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