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FDA 510(k) Application Details - K190493
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K190493
Device Name
Massager, Powered Inflatable Tube
Applicant
Mego Afek AC Ltd.
Kibbutz Afek
Kibbutz Afek 3004200 IL
Other 510(k) Applications for this Company
Contact
Reuven Yunger
Other 510(k) Applications for this Contact
Regulation Number
890.5650
More FDA Info for this Regulation Number
Classification Product Code
IRP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/2019
Decision Date
05/15/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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