Flexitouch System— 510(k) K170216

Name: FDA 510(k) clearance K170216
Creator: U.S. Food and Drug Administration
Published: 2017-05-26

Substantially Equivalent

Tactile Systems Technology, Inc. (Dba Tactile Medical)

FDA 510(k) clearance K170216 for Flexitouch System, Substantially Equivalent on 2017-05-26. 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: 2017-01-24
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOW

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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)

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K203178 — Flexitouch Plus System2020-12-20
K153311 — Flexitouch System2016-09-14

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