# K170506: ECG Check - Universal, ECG Check - Universal Plus

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Designs, Inc.
- Decided: Oct 2, 2017 after 223 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
Longest line of descent: 4 generations back to K963725 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122184: Ecg Check, Cardiac Designs, LLC (2013) Summary page 4.

## Indications for use
The ECG Check Universal family of devices is intended for self-testing by patients at home. These 1-lead cardiac monitors allow remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server. Specifically, the ECG Check Universal models are indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: • Skipped Beats • Pounding Heart (Palpitations) • Heart Racing or Irregular Pulse • Lightheadedness or Faintness • History of Arrhythmias

Source page: https://510kreport.com/device/K170506
Methodology: https://510kreport.com/methodology