Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Road, Yanghe Town
Gaoming District, Foshan City,  CN 528513
Applicant Contact Evan Wong
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Room 304, Building A, 62 Nanyun2 Road
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
-
-