• 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, powered
510(k) Number K111278
Device Name Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
Original Applicant
OTTO BOCK HEALTHCARE, LP
two carlson parkway north
suite 100
minneapolis,  MN  55447 4467
Original Contact william kabitz
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/05/2011
Decision Date 09/16/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-