Compression Therapy Device

Sleeve, Limb, Compressible

Guangzhou Longest Science & Technology Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Longest Science & Technology Co., Ltd. with the FDA for Compression Therapy Device.

Pre-market Notification Details

Device IDK191856
510k NumberK191856
Device Name:Compression Therapy Device
ClassificationSleeve, Limb, Compressible
Applicant Guangzhou Longest Science & Technology Co., Ltd. 5&6f, Building B4, No.11, Kaiyuan Avenue, Science City Guangzhou,  CN 510530
ContactXiaobing Luo
CorrespondentJet Li
Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-11
Decision Date2020-03-19

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