# K030587: External Counterpulsation (Ecp) Model US-Ecp

- Pathway: 510(k) (Traditional)
- Applicant: S-Tct Health, Inc.
- Decided: May 30, 2003 after 94 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 K940264 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940264: Vasogenics Eecp-MC2, Vasogenics, Inc. (1995) Summary page 1.

## Most influential descendants
- K052611: Ecp Health System, Model 2005 (2006), 0 descendants of its own

## Indications for use
S-TCT Health, Inc.’s US-ECP Model IV is a non-invasive external counterpulsating device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock.

Source page: https://510kreport.com/device/K030587
Methodology: https://510kreport.com/methodology