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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 K240329
Device Name Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)
Applicant
Yongkang Youha Electric Appliance Co.,Ltd.
4th Floor,Agricultural Equipment Science and Technology
Innovation Park,No.36,Huahai Road,Chengxi New District
Yongkang,  CN
Applicant Contact Eva Li
Correspondent
Yongkang Youha Electric Appliance Co.,Ltd.
4th Floor,Agricultural Equipment Science and Technology
Innovation Park,No.36,Huahai Road,Chengxi New District
Yongkang,  CN
Correspondent Contact Eva Li
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/05/2024
Decision Date 03/25/2024
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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