# K052611: Ecp Health System, Model 2005

- Pathway: 510(k) (Traditional)
- Applicant: Ecp Health, Inc.
- Decided: Apr 26, 2006 after 216 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: 2 generations back to K940264 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030587: External Counterpulsation (Ecp) Model US-Ecp, S-Tct Health, Inc. (2003) Summary page 1.

## Indications for use
The intended use of the ECP Health System Model 2005 is for the treatment of patients with: (1). Stable or unstable angina pectoris. (2). Acute myocardial infarction (3). Cardiogenic shock (4). Congestive heart failure

Source page: https://510kreport.com/device/K052611
Methodology: https://510kreport.com/methodology