B&J DVT Foot Garments, Models 820 Series

Sleeve, Limb, Compressible

B&J Manufacturing Ltd.

The following data is part of a premarket notification filed by B&j Manufacturing Ltd. with the FDA for B&j Dvt Foot Garments, Models 820 Series.

Pre-market Notification Details

Device IDK201547
510k NumberK201547
Device Name:B&J DVT Foot Garments, Models 820 Series
ClassificationSleeve, Limb, Compressible
Applicant B&J Manufacturing Ltd. Room 701&101, Building 24, Block B, Yuanshan Industrial Zone Gongming Shenzhen,  CN 518106
ContactBilly Yu
CorrespondentFu Ailing
Shenzhen Joyantech Consulting Co., Ltd. Room 1713A, 17F, Block A, Time Square, Xili Town Shenzhen,  CN 518055
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-09
Decision Date2020-09-18

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