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FDA 510(k) Application Details - K071006
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K071006
Device Name
Wheelchair, Powered
Applicant
HEARTWAY MEDICAL PRODUCTS CO., LTD.
NO.58, FU-CHIUN ST.
HSIN-CHU CITY 408 TW
Other 510(k) Applications for this Company
Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2007
Decision Date
05/21/2007
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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