510(k) K253555

Flexitouch® Plus Advanced Pneumatic Compression System by Tactile Medical — Product Code JOW

K253555 is an FDA 510(k) premarket notification submitted by Tactile Medical for the device "Flexitouch® Plus Advanced Pneumatic Compression System". The FDA issued a decision of Substantially Equivalent on July 31, 2026. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Tactile Medical has at least 2 other 510(k) clearances on record.