510(k) Report

Devices descending from K023016

8 later devices reach Nicore Model NCP-1 External Counterpulsation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081359Genesis EcpScottcare Corporation20080—
+1K050172Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc.200501
+1K042413Acs Model NCP-2Applied Cardiac Systems20045—
+2K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc.20250—
+2K152115Renew NCP-5 External Counterpulsation SystemStage 2 Innovations20153—
+3K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC20182—
+4K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.20191—
+5K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.20200—