Product code DRN
- Device name
- Device, Counter-Pulsating, External
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5225
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250756 | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | 2025-12-22 |
| K202108 | External Counterpulsation System, Soulaire | Vamed Medical Instrument Co., Ltd. | 2020-08-28 |
| K191955 | Enhanced External Counter Pulsation Device Plus Omay-A | Omay(Guangzhou)Med Technologies Co., Ltd. | 2020-08-05 |
| K190683 | External Counterpulsation System | Vamed Medical Instrument Co., Ltd. | 2019-09-10 |
| K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC | 2018-05-30 |
| K152115 | Renew NCP-5 External Counterpulsation System | Stage 2 Innovations | 2015-12-17 |
| K130439 | EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING | Chongqing Psk Sci-Tech Development Co., Ltd. | 2013-12-12 |
| K082134 | CIRCULATOR BOOT | Circulator Boot Corp. | 2009-05-07 |
| K081359 | GENESIS ECP | Scottcare Corporation | 2008-05-29 |
| K052611 | ECP HEALTH SYSTEM, MODEL 2005 | Ecp Health, Inc. | 2006-04-26 |
| K050172 | CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 | Cardiomedics, Inc. | 2005-03-31 |
| K042413 | ACS MODEL NCP-2 | Applied Cardiac Systems | 2004-12-09 |
| K033617 | EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY | Vasomedical, Inc. | 2004-03-01 |
| K033657 | MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V | Living Data Technologies Corporation | 2003-12-19 |
| K030587 | EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP | S-Tct Health, Inc. | 2003-05-30 |
| K030532 | CPCA2000 COUNTERPULSATION SYSTEM | Cpca2000, Inc. | 2003-03-14 |
| K021340 | AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE | External Counterpulsation Lab | 2003-01-30 |
| K023701 | ANGIONEW-IV | Living Data Technologies Corporation | 2003-01-30 |
| K022078 | SOLA, COUNTER-PULSATION, MODEL SECP-S | Sola Medical Devices, LLC | 2003-01-10 |
| K023427 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 | Cardiomedics, Inc. | 2003-01-07 |
| K023016 | NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE | Nicore Equipment & Leasing, Inc. | 2002-12-04 |
| K022107 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 | Cardiomedics, Inc. | 2002-08-08 |
| K020857 | EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER | Vasomedical, Inc. | 2002-06-14 |
| K012141 | AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE | External Counterpulsation Lab | 2001-10-25 |
| K010261 | CARDIOMEDICS ECP SYSTEM | Cardiomedics, Inc. | 2001-02-28 |
| K003469 | EECP THERAPY SYSTEM, MODEL TS3 | Vasomedical, Inc. | 2000-12-06 |
| K980937 | NICORE MODEL ESP -1 | Nicore Equipment & Leasing, Inc. | 2000-09-15 |
| K971026 | THE CIRCULATOR BOOT | Circulator Boot Corp. | 1997-08-14 |
| K940264 | VASOGENICS EECP-MC2 | Vasogenics, Inc. | 1995-02-23 |
| K882401 | STONY BROOK MODEL EECP-MC1 | Stony Brook Trading and Development Corp. | 1989-03-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06979448890020 | Huawen | Vamed Medical Instrument Co.,Ltd | 2026-04-17 |
| 06971379470067 | PSK, Air-bag Type Sequential External Counter-pulsation Device | Chongqing PSK-Health Sci-Tech Development Co.,Ltd. | 2025-04-15 |
| 06971379470074 | PSK, Air-bag Type Sequential External Counter-pulsation Device | Chongqing PSK-Health Sci-Tech Development Co.,Ltd. | 2025-04-15 |
| 06975435800058 | Omay | Omay(Guangzhou) Med Technologies Co.,Ltd | 2023-12-21 |
| 00865089000316 | RenewTM NCP-5 External Counterpulsation System | S2 Equipment LLC | 2018-06-25 |
| 06971379470012 | ECP PSK | Chongqing PSK-Health Sci-Tech Development Co.,Ltd. | 2017-12-04 |
| 06971379470029 | ECP PSK | Chongqing PSK-Health Sci-Tech Development Co.,Ltd. | 2017-12-04 |
| 00868331000409 | RejuvaHeart | NORTH AMERICAN ECP INC. | 2017-10-17 |
| 08883000001640 | RenewTM NCP-5 External Counterpulsation System | RENEW GROUP PRIVATE LIMITED | 2017-03-15 |
| 00817980020948 | Cuff Set, Medium | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020931 | Cuff Set, Small | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020924 | Cuff Set, X-Small | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020917 | Electrodes (600 per case) | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020900 | ECG Cable Adaptor-for use with V10-0017 (Model TS3) | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020894 | 3 Lead Integrated ECG Cable with adapter (Model TS3) | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020887 | 3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™) | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020870 | 3 Lead Integrated ECG Cable (AngioNew® V & VI) | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020863 | Signa Electrode Gel, 2 oz | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020856 | Signa Electrode Gel, 8 oz | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020849 | Nu Prep Gel, 4 oz (3 PK) | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020832 | Roll ECG Paper, 240 ft. (Model MC2) | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020825 | Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020818 | Vasomedical™ TS-4EECP® Therapy System | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020801 | Vasomedical™ TS-4 EECP® Therapy System | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020795 | Vasomedical™Lumenair™ EECP® Therapy System | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020788 | Vasomedical™Lumenair™ EECP® Therapy System | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020771 | Vasomedical™ AngioNew -VI EECP® Therapy System | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020764 | Vasomedical™ AngioNew -VI EECP® Therapy System | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020757 | Vasomedical™ AngioNew -V EECP® Therapy System | VASOMEDICAL, INC. | 2016-11-29 |
| 00817980020740 | Vasomedical™ AngioNew -V EECP® Therapy System | VASOMEDICAL, INC. | 2016-11-29 |