Flexitouch Plus System— 510(k) K203178

Name: FDA 510(k) clearance K203178
Creator: U.S. Food and Drug Administration
Published: 2020-12-20

Substantially Equivalent

Tactile Systems Technology, Inc. (Dba Tactile Medical)

FDA 510(k) clearance K203178 for Flexitouch Plus System, Substantially Equivalent on 2020-12-20. Applicant: Tactile Systems Technology, Inc. (Dba Tactile Medical). Device class: 2.

Clearance details

Applicant: Tactile Systems Technology, Inc. (Dba Tactile Medical)
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2020-10-26
Decision date: 2020-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brighton, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOW

view all

K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)2026-09-11
K254217 — Aerloom2026-08-31
K253555 — Flexitouch® Plus Advanced Pneumatic Compression System2026-07-31
K253386 — DVT Garment2026-06-25
K250242 — Compression Therapy Device (LGT-2202DVT)2026-04-24

More clearances from Tactile Systems Technology, Inc. (Dba Tactile Medical)

view all

K170216 — Flexitouch System2017-05-26
K153311 — Flexitouch System2016-09-14

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