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FDA 510(k) Application Details - K151797
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K151797
Device Name
Wheelchair, Mechanical
Applicant
NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD.
57 LONGFEI ROAD, YUNLONG INDUSTRY ZONE, YINGZHOU DISTRICT
NINGBO 315135 CN
Other 510(k) Applications for this Company
Contact
CHARLES SHEN
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
07/02/2015
Decision Date
08/25/2015
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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