FDA 510(k)

Flexitouch System

K-Number: K153311 · 2016-09-14

ApplicantTactile Systems Technology, Inc. (Dba Tactile Medical)

Decision Date2016-09-14

Product CodePPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Flexitouch System is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Systems Technology, Inc. (Dba Tactile Medical). It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K153311. The device is classified under product code PPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexitouch System?

Flexitouch System is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Tactile Systems Technology, Inc. (Dba Tactile Medical). The 510(k) number is K153311.

When did Flexitouch System receive FDA 510(k) clearance?

Flexitouch System received FDA 510(k) clearance on 2016-09-14, under 510(k) number K153311.

Who is the listed applicant for Flexitouch System?

The FDA 510(k) record lists Tactile Systems Technology, Inc. (Dba Tactile Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexitouch System?

The FDA product code for Flexitouch System is PPS.

Other records listing Tactile Systems Technology, Inc. (Dba Tactile Medical) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203178Flexitouch Plus System K170216Flexitouch System

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.