510(k) Report

Devices descending from K173483

2 later devices reach Pure Flow External Counter-Pulsation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.20191—
+2K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.20200—