CIRCUL8 Luxe DVT Prevention Device

Sleeve, Limb, Compressible

Ortho8 Inc.

The following data is part of a premarket notification filed by Ortho8 Inc. with the FDA for Circul8 Luxe Dvt Prevention Device.

Pre-market Notification Details

Device IDK211235
510k NumberK211235
Device Name:CIRCUL8 Luxe DVT Prevention Device
ClassificationSleeve, Limb, Compressible
Applicant Ortho8 Inc. 2217 Plaza Drive Rocklin,  CA  95765
ContactTaylor Nordeen
CorrespondentJohn Beasley
MedTech Review, LLC 257 Garnet Garden Street Henderson,  NV  89015
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-09-08

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