Genesis Ecp
FDA 510(k) K081359 · Scottcare Corporation
510(k) numberK081359
Submission
- Device name
- Genesis Ecp
- Applicant
- Scottcare Corporation
Cleveland, OH, US - Received
- May 15, 2008
- Decision date
- May 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRN – Device, Counter-Pulsating, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5225
- Specialty
- Cardiovascular
Other 510(k)s with product code DRN
| 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 |
| 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 |
More from Cardiomedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250259 | TeleRehab Aermos Cardiopulmonary RehabilitationDRG · Traditional | 06/04/2025SE |
| K142180 | TelesenseDSI · Traditional | 12/12/2014SE |
| K092947 | Telesentry, Model TS01DSI · Traditional | 02/26/2010SE |
| K083382 | Chroma, Model: RZ153CMWJ · Traditional | 08/13/2009SE |
| K050778 | Telerehad 2004DRG · Traditional | 04/13/2005SE |
| K895719 | Telerehab System for Cardiac RehabilitationDXH · Traditional | 03/06/1990SE |
Questions and answers
When was Genesis Ecp cleared by the FDA?
Genesis Ecp (K081359) received a 510(k) decision of Substantially Equivalent on May 29, 2008, 14 days after the submission was received.
What is the product code of K081359?
The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.