Flexitouch® Plus Advanced Pneumatic Compression System

FDA 510(k) K253555 · Tactile Medical

Substantially Equivalent

510(k) numberK253555

Submission

Device name
Flexitouch® Plus Advanced Pneumatic Compression System
Applicant
Tactile Medical
Minneapolis, MN, US
Received
November 14, 2025
Decision date
July 31, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

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K253386DVT GarmentJOW · Traditional Vistar Medical Supplies Co., Ltd.06/25/2026SE
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K254267NanoPress 760A-BT (760A-BT)JOW · Traditional Mego Afek , Ltd.02/24/2026SE
K250974Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional Bio Compression Systems, Inc.12/12/2025SE
K250190Sequential Compression System (SCD600)JOW · Traditional Shenzhen Comen Medical Instruments Co.,Ltd12/08/2025SE
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special Wellell, Inc.10/28/2025SE
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special Manamed, LLC09/17/2025SE
K251086PnueAira (PNCU-01)JOW · Traditional Biotab, LLC08/18/2025SE

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Questions and answers

When was Flexitouch® Plus Advanced Pneumatic Compression System cleared by the FDA?

Flexitouch® Plus Advanced Pneumatic Compression System (K253555) received a 510(k) decision of Substantially Equivalent on July 31, 2026, 259 days after the submission was received.

What is the product code of K253555?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.