FDA 510(k) Application Details - K061273

Device Classification Name Wheelchair, Mechanical

  More FDA Info for this Device
510(K) Number K061273
Device Name Wheelchair, Mechanical
Applicant NOVA ORTHO-MED, INC.
345 WEST VICTORIA ST.
GARDENA, CA 90248 US
Other 510(k) Applications for this Company
Contact SUE CHEN
Other 510(k) Applications for this Contact
Regulation Number 890.3850

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

  More FDA Info for this Product Code
Date Received 05/08/2006
Decision Date 05/23/2006
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 Y
Expedited Review



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