# K122184: Ecg Check

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Designs, LLC
- Decided: Feb 14, 2013 after 206 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: 3 generations back to K963725 (1997). 5 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042254: PMP4 Selfcheck Ecg, Card Guard Scientific Survival, Ltd. (2005) Summary page 1.

## Most influential descendants
- K140933: Alivecor Heart Monitor (2014), 28 descendants of its own
- K142743: AliveCor Heart Monitor (2015), 19 descendants of its own
- K171816: Kardia Band System (2017), 12 descendants of its own
- K201456: Scan Monitor (2021), 6 descendants of its own
- K181823: KardiaAI (2019), 6 descendants of its own

## Indications for use
The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their EGG data to medical professionals via a communication device to a remote server. Specifically, the EGG Check is 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/K122184
Methodology: https://510kreport.com/methodology