Flexitouch System
K-Number: K153311 · 2016-09-14
Decision Date2016-09-14
Product CodePPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Flexitouch System is a medical device manufactured by Tactile Systems Technology, Inc. (Dba Tactile Medical). It received FDA 510(k) clearance on 2016-09-14 under approval 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. It is manufactured by Tactile Systems Technology, Inc. (Dba Tactile Medical). The 510(k) number is K153311.
When was Flexitouch System approved by the FDA?
Flexitouch System received FDA 510(k) clearance on 2016-09-14, under approval number K153311.
What company makes Flexitouch System?
Flexitouch System is manufactured by Tactile Systems Technology, Inc. (Dba Tactile Medical).
What is the FDA product code for Flexitouch System?
The FDA product code for Flexitouch System is PPS.
Other Devices by Tactile Systems Technology, Inc. (Dba Tactile Medical)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.