510(k) K203178

Flexitouch Plus System by Tactile Systems Technology, Inc. (Dba Tactile Medical) — Product Code JOW

K203178 is an FDA 510(k) premarket notification submitted by Tactile Systems Technology, Inc. (Dba Tactile Medical) for the device "Flexitouch Plus System". The FDA issued a decision of Substantially Equivalent on December 20, 2020. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Tactile Systems Technology, Inc. (Dba Tactile Medical) has at least 2 other 510(k) clearances on record.