# K022078: Sola, Counter-Pulsation, Model Secp-S

- Pathway: 510(k) (Traditional)
- Applicant: Sola Medical Devices, LLC
- Decided: Jan 10, 2003 after 198 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
This device can be used for the treatment of: The Sola Counter-Pulsating device is a non invasive external counterpulsation device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction, cardiogenic shock and congestive heart failure.

Source page: https://510kreport.com/device/K022078
Methodology: https://510kreport.com/methodology