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DRN — Device, Counter-Pulsating, External Class II

FDA Device Classification

Classification Details

Product Code
DRN
Device Class
Class II
Regulation Number
870.5225
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250756pressionPression Wave PRO External Counter-Pulsation SystemDecember 22, 2025
K202108vamed medical instrument coExternal Counterpulsation System, SoulaireAugust 28, 2020
K191955omay(guangzhou)med technologies coEnhanced External Counter Pulsation Device Plus Omay-AAugust 5, 2020
K190683vamed medical instrument coExternal Counterpulsation SystemSeptember 10, 2019
K173483xtreem pulsePure Flow External Counter-Pulsation DeviceMay 30, 2018
K152115stage 2 innovationsRenew NCP-5 External Counterpulsation SystemDecember 17, 2015
K130439chongqing psk sci-tech development coEXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORINGDecember 12, 2013
K082134circulator bootCIRCULATOR BOOTMay 7, 2009
K081359scottcare corporationGENESIS ECPMay 29, 2008
K052611ecp healthECP HEALTH SYSTEM, MODEL 2005April 26, 2006
K050172cardiomedicsCARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000March 31, 2005
K042413applied cardiac systemsACS MODEL NCP-2December 9, 2004
K033617vasomedicalEECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRYMarch 1, 2004
K033657living data technologies corporationMOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-VDecember 19, 2003
K030587s-tct healthEXTERNAL COUNTERPULSATION (ECP) MODEL US-ECPMay 30, 2003
K030532cpca2000CPCA2000 COUNTERPULSATION SYSTEMMarch 14, 2003
K023701living data technologies corporationANGIONEW-IVJanuary 30, 2003
K021340external counterpulsation labAECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICEJanuary 30, 2003
K022078sola medical devicesSOLA, COUNTER-PULSATION, MODEL SECP-SJanuary 10, 2003
K023427cardiomedicsCARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000January 7, 2003