FDA 510(k) Application Details - K190015

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K190015
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	01/03/2019
Decision Date	03/25/2019
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