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FDA 510(k) Application Details - K192466
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K192466
Device Name
Massager, Powered Inflatable Tube
Applicant
Shenzhen Lifotronic Technology Co., Ltd.
Unit A, 4th Floor, Building 15, No.1008 Songbai Road
Nanshan District
ShenZhen 518055 CN
Other 510(k) Applications for this Company
Contact
Xiang Lei
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
09/09/2019
Decision Date
06/22/2020
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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