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FDA 510(k) Application Details - K043332
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K043332
Device Name
Wheelchair, Mechanical
Applicant
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
111-X60, LANE 68
FU-HSING N. RD.
TAICHUNG 407 TW
Other 510(k) Applications for this Company
Contact
ZEN-JYE CHEN
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
12/02/2004
Decision Date
12/13/2004
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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