Flexitouch System— 510(k) K153311

Name: FDA 510(k) clearance K153311
Creator: U.S. Food and Drug Administration
Published: 2016-09-14

Substantially Equivalent

Tactile Systems Technology, Inc. (Dba Tactile Medical)

FDA 510(k) clearance K153311 for Flexitouch System, Substantially Equivalent on 2016-09-14. Applicant: Tactile Systems Technology, Inc. (Dba Tactile Medical). Device class: 2.

Clearance details

Applicant: Tactile Systems Technology, Inc. (Dba Tactile Medical)
Product code: Code PPS
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2015-11-17
Decision date: 2016-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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