# K130439: External Counterpulsation Device with SP02 Mornitoring

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Psk Sci-Tech Development Co., Ltd.
- Decided: Dec 12, 2013 after 294 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K190683: External Counterpulsation System (2019), 1 descendant of its own
- K202108: External Counterpulsation System, Soulaire (2020), 0 descendants of its own
- K191955: Enhanced External Counter Pulsation Device Plus Omay-A (2020), 0 descendants of its own

## Indications for use
The intended use of the 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/K130439
Methodology: https://510kreport.com/methodology