Lympha-Flow(LF1200)

Massager, Powered Inflatable Tube

DaeSung Maref Co., Ltd

The following data is part of a premarket notification filed by Daesung Maref Co., Ltd with the FDA for Lympha-flow(lf1200).

Pre-market Notification Details

Device IDK160178
510k NumberK160178
Device Name:Lympha-Flow(LF1200)
ClassificationMassager, Powered Inflatable Tube
Applicant DaeSung Maref Co., Ltd 298-24, Gongdan-ro Gunpo-si,  KR 15809
ContactJae-wha Lee
CorrespondentDave Kim
Mtech Group 8310 Buffalo Speedway Houston,  TX  77025
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-27
Decision Date2017-01-11
Summary:summary

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