FDA 510(k) Application Details - K101524

Device Classification Name Wheelchair, Powered

  More FDA Info for this Device
510(K) Number K101524
Device Name Wheelchair, Powered
Applicant OTTO BOCK HEALTH CARE, LP
TWO CARLSON PARKWAY NORTH
SUITE 100
MINNEAPOLIS, MN 55447 US
Other 510(k) Applications for this Company
Contact WILLIAM KABITZ
Other 510(k) Applications for this Contact
Regulation Number 890.3860

  More FDA Info for this Regulation Number
Classification Product Code ITI
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/02/2010
Decision Date 09/29/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact