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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 K253555
Device Name Flexitouch® Plus Advanced Pneumatic Compression System
Applicant
Tactile Medical
3701 Wayzata Blvd.
Minneapolis,  MN  55416
Applicant Contact Sunday Hoy
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Mark Spreeman
Regulation Number870.5800
Classification Product Code
JOW  
Subsequent Product Code
PPS  
Date Received11/14/2025
Decision Date 07/31/2026
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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