• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name wheelchair, mechanical
510(k) Number K120526
Device Name YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
Original Applicant
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
333 pfingsten road
northbrook,  IL  60062
Original Contact ned devine
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/22/2012
Decision Date 03/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-