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FDA 510(k) Application Details - K140023
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K140023
Device Name
Wheelchair, Mechanical
Applicant
PDG PRODUCT DESIGN GROUP, INC.
5905 FAWN LANE
CLEVELAND, OH 44141 US
Other 510(k) Applications for this Company
Contact
EDWARD A KROLL
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
01/06/2014
Decision Date
10/16/2014
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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