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FDA 510(k) Application Details - K151893
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K151893
Device Name
Wheelchair, Mechanical
Applicant
FREEDOM DESIGNS, INC.
2241 MADERA ROAD
SIMI VALLEY, CA 93065 US
Other 510(k) Applications for this Company
Contact
Nancy F Schmidt
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
07/10/2015
Decision Date
10/22/2015
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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