# K042254: PMP4 Selfcheck Ecg

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Jan 13, 2005 after 146 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: 2 generations back to K963725 (1997). 4 ancestors in all.
99 later devices descend from it; 7 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012223: CG-2211 Selfcheck Ecg Transmitter, Card Guard Scientific Survival, Ltd. (2001) Summary page 6.
- K964836: Card Guard, Model CG-7100, Card Guard Scientific Survival, Ltd. (1997) Summary page 6.

## Most influential descendants
- K060911: CG-6108 Arrhythmia Ecg Event Recorder (2006), 44 descendants of its own
- K122184: Ecg Check (2013), 30 descendants of its own
- K140933: Alivecor Heart Monitor (2014), 28 descendants of its own
- K071995: CG-6108 Continuous Ecg Monitor and Arrhythmia Detector (2007), 25 descendants of its own
- K142743: AliveCor Heart Monitor (2015), 19 descendants of its own

## Indications for use
The PMP4 SelfCheckm ECG and Card Guard Heart Screening Service are intended for self-testing by patients and by health care professionals at home and at medical settings. This 12- lead and 1-lead electrocardiogram (ECG), allows remote patients tb display and transmit their ECG data to medical professionals via a communication device to a remote server. Specifically, the PMP4 SelfCheckm ECG is intended 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/K042254
Methodology: https://510kreport.com/methodology