• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K120032
Model AE-604M
Device Name MECHANICAL WHEELCHAIR
Original Applicant
AIKIN HEALTHCARE CO., LTD
5401 s. cottonwood ct.
greenwood village,  CO  80121
Original Contact kevin walls
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/04/2012
Decision Date 04/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-