FDA 510(k) Application Details - K090108

Device Classification Name Wheelchair, Powered

  More FDA Info for this Device
510(K) Number K090108
Device Name Wheelchair, Powered
Applicant HOVEROUND CORP.
2151 WHITFIELD INDUSTRIAL WAY
SARASOTA, FL 34243 US
Other 510(k) Applications for this Company
Contact TONY DIGIOVANNI
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 01/15/2009
Decision Date 03/19/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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