510(k) Report

Devices descending from K152115

3 later devices reach Renew NCP-5 External Counterpulsation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC20182—
+2K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.20191—
+3K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.20200—