510(k) Report

Devices descending from K042413

5 later devices reach Acs Model NCP-2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc.20250—
+1K152115Renew NCP-5 External Counterpulsation SystemStage 2 Innovations20153—
+2K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC20182—
+3K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.20191—
+4K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.20200—