510(k) Report

Devices descending from K012008

3 later devices reach STS Range , Models STS20,STS30,STS40 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133119Flowtron ACS800 Pump and Tri Pulse GarmentsArjohuntleigh Polska SP Z.O.O.20142—
+2K143438Flowtron ACS900Getinge (Suzhou) Co., Ltd.201511
+3K191937Ezvena IPC, Ezvena SQSEezcare Medical Corp20200—