510(k) K173483

Pure Flow External Counter-Pulsation Device by Xtreem Pulse, LLC — Product Code DRN

K173483 is an FDA 510(k) premarket notification submitted by Xtreem Pulse, LLC for the device "Pure Flow External Counter-Pulsation Device". The FDA issued a decision of Substantially Equivalent on May 30, 2018. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Xtreem Pulse, LLC has at least 4 other 510(k) clearances on record.