Device, Counter-Pulsating, External
FDA product code DRN · Class II (moderate risk) · 21 CFR 870.5225 · Cardiovascular
34510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Cardiomedics, Inc. 5
- Circulator Boot Corp. 4
- Vasomedical, Inc. 3
- Vamed Medical Instrument Co., Ltd. 2
- Nicore Equipment & Leasing, Inc. 2
- External Counterpulsation Lab 2
- Living Data Technologies Corporation 2
- Cpca2000, Inc. 1
- Pression, Inc. 1
- Omay(Guangzhou)Med Technologies Co., Ltd. 1
- Xtreem Pulse, LLC 1
- Stage 2 Innovations 1
- Chongqing Psk Sci-Tech Development Co., Ltd. 1
- Scottcare Corporation 1
- Ecp Health, Inc. 1
- Applied Cardiac Systems 1
- S-Tct Health, Inc. 1
- Sola Medical Devices, LLC 1
- Vasogenics, Inc. 1
- Stony Brook Trading and Development Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250756 | Pression Wave PRO External Counter-Pulsation SystemDRN · Traditional | Pression, Inc. | 12/22/2025SE |
| K202108 | External Counterpulsation System, SoulaireDRN · Special | Vamed Medical Instrument Co., Ltd. | 08/28/2020SE |
| K191955 | Enhanced External Counter Pulsation Device Plus Omay-ADRN · Traditional | Omay(Guangzhou)Med Technologies Co., Ltd. | 08/05/2020SE |
| K190683 | External Counterpulsation SystemDRN · Traditional | Vamed Medical Instrument Co., Ltd. | 09/10/2019SE |
| K173483 | Pure Flow External Counter-Pulsation DeviceDRN · Traditional | Xtreem Pulse, LLC | 05/30/2018SE |
| K152115 | Renew NCP-5 External Counterpulsation SystemDRN · Traditional | Stage 2 Innovations | 12/17/2015SE |
| K130439 | External Counterpulsation Device with SP02 MornitoringDRN · Traditional | Chongqing Psk Sci-Tech Development Co., Ltd. | 12/12/2013SE |
| K082134 | Circulator BootDRN · Traditional | Circulator Boot Corp. | 05/07/2009SE |
| K081359 | Genesis EcpDRN · Special | Scottcare Corporation | 05/29/2008SE |
| K052611 | Ecp Health System, Model 2005DRN · Traditional | Ecp Health, Inc. | 04/26/2006SE |
| K050172 | Cardiassist Counter Pulsation System Series 4000/5000DRN · Traditional | Cardiomedics, Inc. | 03/31/2005SE |
| K042413 | Acs Model NCP-2DRN · Traditional | Applied Cardiac Systems | 12/09/2004SE |
| K033617 | Eecp Therapy System Model TS4 With/Without Pluse OximetryDRN · Traditional | Vasomedical, Inc. | 03/01/2004SE |
| K033657 | Mobile External Counter Pulsation System Angionew-VDRN · Special | Living Data Technologies Corporation | 12/19/2003SE |
| K030587 | External Counterpulsation (Ecp) Model Us-EcpDRN · Traditional | S-Tct Health, Inc. | 05/30/2003SE |
| K030532 | CPCA2000 Counterpulsation SystemDRN · Traditional | Cpca2000, Inc. | 03/14/2003SE |
| K023701 | Angionew-IvDRN · Traditional | Living Data Technologies Corporation | 01/30/2003SE |
| K021340 | Aecp-A, Automatic External Counterpulsation DeviceDRN · Traditional | External Counterpulsation Lab | 01/30/2003SE |
| K022078 | Sola, Counter-Pulsation, Model Secp-SDRN · Traditional | Sola Medical Devices, LLC | 01/10/2003SE |
| K023427 | Cardiassist Counterpulsation System, Model Mark 3000DRN · Traditional | Cardiomedics, Inc. | 01/07/2003SE |
| K023016 | Nicore Model NCP-1 External Counterpulsation DeviceDRN · Traditional | Nicore Equipment & Leasing, Inc. | 12/04/2002SE |
| K022107 | Cardiassist Counterpulsation System, Model Mark 3000DRN · Traditional | Cardiomedics, Inc. | 08/08/2002SE |
| K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation…DRN · Traditional | Vasomedical, Inc. | 06/14/2002SE |
| K012141 | Aecp-A, Automatic External Counterpulsation DeviceDRN · Traditional | External Counterpulsation Lab | 10/25/2001SE |
| K010261 | Cardiomedics Ecp SystemDRN · Special | Cardiomedics, Inc. | 02/28/2001SE |
| K003469 | Eecp Therapy System, Model TS3DRN · Special | Vasomedical, Inc. | 12/06/2000SE |
| K980937 | Nicore Model Esp -1DRN · Traditional | Nicore Equipment & Leasing, Inc. | 09/15/2000SE |
| K971026 | The Circulator BootDRN · Traditional | Circulator Boot Corp. | 08/14/1997SE |
| K940264 | Vasogenics EECP-MC2DRN · Traditional | Vasogenics, Inc. | 02/23/1995SE |
| K882401 | Stony Brook Model EECP-MC1DRN · Traditional | Stony Brook Trading and Development Corp. | 03/03/1989SE |
| K872034 | Cardiomedics External Counterpulsation SystemDRN · Traditional | Cardiomedics, Inc. | 09/18/1987SE |
| K833627 | Circulator MinibootDRN · Traditional | Circulator Boot Corp. | 05/23/1984SE |
| K792430 | Cardiassist External CounterpulsationDRN · Traditional | Cardiassist Corp. | 01/23/1980SE |
| K792354 | The Circulator BootDRN · Traditional | Circulator Boot Corp. | 01/09/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1582-2009 | Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device…Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a… | Cardiomedics Incorporated | 04/09/2009Terminated |