B&J DVT Calf/Thigh Garments, Models 801/830 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 Calf/thigh Garments, Models 801/830 Series.

Pre-market Notification Details

Device IDK201532
510k NumberK201532
Device Name:B&J DVT Calf/Thigh Garments, Models 801/830 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-09-19

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