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FDA 510(k) Application Details - K131529
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K131529
Device Name
Wheelchair, Mechanical
Applicant
PINGDINGSHAN SHENXING HEALTHCARE TECHNOLOGY CO., L
XINXING RD. SOUTH OF INDUSTRIAL PARK
LUSHAN COUNTY
PINGDINGSHAN CITY, HENAN CN
Other 510(k) Applications for this Company
Contact
WANG QING
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
05/28/2013
Decision Date
09/24/2013
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
Y
Expedited Review
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