Flexitouch® Plus Advanced Pneumatic Compression System— 510(k) K253555

Name: FDA 510(k) clearance K253555
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Tactile Medical

FDA 510(k) clearance K253555 for Flexitouch® Plus Advanced Pneumatic Compression System, Substantially Equivalent on 2026-07-31. Applicant: Tactile Medical. Device class: 2.

Clearance details

Applicant: Tactile Medical
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2025-11-14
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K250974 — Bio Arterial Deluxe (IC-BAP-DX)2025-12-12
K250190 — Sequential Compression System (SCD600)2025-12-08

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Data sourced from openFDA. This site is unofficial and independent of the FDA.