Flexitouch Plus System
K-Number: K203178 · 2020-12-20
Decision Date2020-12-20
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Flexitouch Plus System is a medical device manufactured by Tactile Systems Technology, Inc. (Dba Tactile Medical). It received FDA 510(k) clearance on 2020-12-20 under approval number K203178. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Flexitouch Plus System?
Flexitouch Plus System is a medical device that received FDA 510(k) clearance on 2020-12-20. It is manufactured by Tactile Systems Technology, Inc. (Dba Tactile Medical). The 510(k) number is K203178.
When was Flexitouch Plus System approved by the FDA?
Flexitouch Plus System received FDA 510(k) clearance on 2020-12-20, under approval number K203178.
What company makes Flexitouch Plus System?
Flexitouch Plus System is manufactured by Tactile Systems Technology, Inc. (Dba Tactile Medical).
What is the FDA product code for Flexitouch Plus System?
The FDA product code for Flexitouch Plus System is JOW.
Other Devices by Tactile Systems Technology, Inc. (Dba Tactile Medical)
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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.