# K033617: Eecp Therapy System Model TS4 with/Without Pluse Oximetry

- Pathway: 510(k) (Traditional)
- Applicant: Vasomedical, Inc.
- Decided: Mar 1, 2004 after 104 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020857: Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter, Vasomedical, Inc. (2002) Summary page 2.

## Indications for use
Vasomedical, Inc.'s Enhanced External Counterpulsation (EECP®) Therapy Systems are non-invasive external counterpulsation devices intended for use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock

Source page: https://510kreport.com/device/K033617
Methodology: https://510kreport.com/methodology