# K020857: Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter

- Pathway: 510(k) (Traditional)
- Applicant: Vasomedical, Inc.
- Decided: Jun 14, 2002 after 88 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). 2 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003469: Eecp Therapy System, Model TS3, Vasomedical, Inc. (2000) Summary page 1.
- K940264: Vasogenics Eecp-MC2, Vasogenics, Inc. (1995) Summary page 1.

## Most influential descendants
- K022107: Cardiassist Counterpulsation System, Model Mark 3000 (2002), 3 descendants of its own
- K023701: Angionew-IV (2003), 1 descendant of its own
- K023427: Cardiassist Counterpulsation System, Model Mark 3000 (2003), 1 descendant of its own
- K082134: Circulator Boot (2009), 0 descendants of its own
- K050172: Cardiassist Counter Pulsation System Series 4000/5000 (2005), 0 descendants of its own

## Indications for use
Vasomedical, Inc.’s EECP® Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock. Vasomedical, Inc.’s EECP® Therapy System Model TS3 is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock. Vasomedical, Inc.’s Enhanced External Counterpulsation EECP® MC-2 is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.

Source page: https://510kreport.com/device/K020857
Methodology: https://510kreport.com/methodology