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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K180309
Device Name Manual Wheelchair W54
Applicant
Jiangsu Jumao Medical Equipment Co., Ltd.
#36 Danyan Rd.
Danyang,  CN 212300
Applicant Contact Qian Gao
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 215, Huaming Bldg., Chebei Rd.
Guangzhou,  CN 511660
Correspondent Contact Jinghua Zhou
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/02/2018
Decision Date 05/03/2019
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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