FDA 510(k) Application Details - K163432

Device Classification Name Wheelchair, Mechanical

  More FDA Info for this Device
510(K) Number K163432
Device Name Wheelchair, Mechanical
Applicant PDG Product Design Group, Inc
103 - 318 East Kent Ave. South
Vancouver V5X4NC CA
Other 510(k) Applications for this Company
Contact Torr Brown
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 12/07/2016
Decision Date 06/27/2017
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