Flexitouch Plus System

Sleeve, Limb, Compressible

Tactile Systems Technology, Inc. (DBA Tactile Medical)

The following data is part of a premarket notification filed by Tactile Systems Technology, Inc. (dba Tactile Medical) with the FDA for Flexitouch Plus System.

Pre-market Notification Details

Device IDK203178
510k NumberK203178
Device Name:Flexitouch Plus System
ClassificationSleeve, Limb, Compressible
Applicant Tactile Systems Technology, Inc. (DBA Tactile Medical) 151 5th Ave NW Suite 100 New Brighton,  MN  55112
ContactBrett Demchuk
CorrespondentLauren Barnes
The Tamarack Group – MPLS, LLC 2584 Upton Avenue South Minneapolis,  MN  55405
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-26
Decision Date2020-12-20

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