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 K082314
Device Name BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
Applicant
Otto Bock Healthcare LP
2247 Jennifer Ln.
St Paul,  MN  55109
Applicant Contact WILLIAM JACKSON
Correspondent
Otto Bock Healthcare LP
2247 Jennifer Ln.
St Paul,  MN  55109
Correspondent Contact WILLIAM JACKSON
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/13/2008
Decision Date 10/28/2008
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
-
-