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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K203178
Device Name Flexitouch Plus System
Applicant
Tactile Systems Technology, Inc. (Dba Tactile Medical)
151 5th Ave. NW Suite 100
New Brighton,  MN  55112
Applicant Contact Brett Demchuk
Correspondent
The Tamarack Group – Mpls, LLC
2584 Upton Ave. S.
Minneapolis,  MN  55405
Correspondent Contact Lauren Barnes
Regulation Number870.5800
Classification Product Code
JOW  
Subsequent Product Code
PPS  
Date Received10/26/2020
Decision Date 12/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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