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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
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