Venen-trainer (Model: FM150, SFM90)

Sleeve, Limb, Compressible

Shenzhen Pango Electronic CO., LTD

The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd with the FDA for Venen-trainer (model: Fm150, Sfm90).

Pre-market Notification Details

Device IDK203746
510k NumberK203746
Device Name:Venen-trainer (Model: FM150, SFM90)
ClassificationSleeve, Limb, Compressible
Applicant Shenzhen Pango Electronic CO., LTD No.25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang Distict Shenzhen,  CN 518115
ContactGuojun Zeng
CorrespondentCassie Lee
Guangzhou Glomed Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510000
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-22
Decision Date2021-11-10

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