# K081359: Genesis Ecp

- Pathway: 510(k) (Special)
- Applicant: Scottcare Corporation
- Decided: May 29, 2008 after 14 days
- Product code: DRN (Device, Counter-Pulsating, External)
- Device class: 2
- Regulation: 21 CFR 870.5225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023016 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023016: Nicore Model NCP-1 External Counterpulsation Device, Nicore Equipment & Leasing, Inc. (2002) Summary page 1.

## Indications for use
The intended use of the ScottCare Genesis ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

Source page: https://510kreport.com/device/K081359
Methodology: https://510kreport.com/methodology