# K081471: Ecard and Ccard

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Jun 24, 2008 after 28 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The eCARD is a prescription only single patient use, event recording ECG monitor that can be worn for up to 30 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains. The cCARD is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 7 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

Source page: https://510kreport.com/device/K081471
Methodology: https://510kreport.com/methodology