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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 K213790
Device Name Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
Applicant
Mobility Source Medical Technology Co., Ltd.
160 Heheng Rd., Yanghe Town
Gaoming District, Foshan City,  CN 528513
Applicant Contact Evan Wong
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 304, Bldg. A, 62 Nanyun2 Rd.
Huangpu District, Science City,  CN 510663
Correspondent Contact Shanfeng Jiang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/06/2021
Decision Date 03/14/2022
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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