FDA 510(k) Application Details - K010364

Device Classification Name Wheelchair, Powered

  More FDA Info for this Device
510(K) Number K010364
Device Name Wheelchair, Powered
Applicant INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA, OH 44036 US
Other 510(k) Applications for this Company
Contact RAE ANN FARROW
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 02/07/2001
Decision Date 03/22/2001
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