# K190683: External Counterpulsation System

- Pathway: 510(k) (Traditional)
- Applicant: Vamed Medical Instrument Co., Ltd.
- Decided: Sep 10, 2019 after 176 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: 4 generations back to K980937 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130439: External Counterpulsation Device with SP02 Mornitoring, Chongqing Psk Sci-Tech Development Co., Ltd. (2013) Summary page 5.
- K173483: Pure Flow External Counter-Pulsation Device, Xtreem Pulse, LLC (2018) Summary page 5.

## Most influential descendants
- K202108: External Counterpulsation System, Soulaire (2020), 0 descendants of its own

## Indications for use
The ECP-MC3 device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

Source page: https://510kreport.com/device/K190683
Methodology: https://510kreport.com/methodology