# K012223: CG-2211 Selfcheck Ecg Transmitter

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Sep 10, 2001 after 56 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: 1 generation back to K963725 (1997). 2 ancestors in all.
181 later devices descend from it; 5 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963725: Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified), Card Guard, Ltd. (1997) Summary page 3.
- K010945: Heartcard, Model 5258, Instromedix (2001) Summary page 3.

## Most influential descendants
- K042254: PMP4 Selfcheck Ecg (2005), 99 descendants of its own
- K052767: Afibalert Atrial Fibrillation Detector (2006), 47 descendants of its own
- K060911: CG-6108 Arrhythmia Ecg Event Recorder (2006), 44 descendants of its own
- K071228: Fidelity 200 Cardiac Event Recorder (2007), 32 descendants of its own
- K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini) (2013), 31 descendants of its own

## Indications for use
The CG-2211 SelfCheck ECG Transmitter and LifeWatch Heart Screening Service are intended for self-testing by patients who are concerned about their heart rhythm (i.e. during or after exercise) or who experience the following symptoms that are suggestive of abnormal heart rhythms, and who would like to monitor these symptoms: Skipped Beats Pounding heart (Palpitations) Heart Racing or Irregular Pulse Lightheadedness or Faintness History of Arrhythmias Contraindications for Use: In order to use this service, the patient must be able to perform all of the following: Read and understand the User’s Manual Place the HeartCard on his/her chest and hold it steadily for at least 30 seconds. Hear the “beeps” for low battery. Speak and understand English. Operate a telephone. Operate a simple, push-button device. Due to the possible seriousness of the abnormal heart rhythms that can be associated with these conditions, persons who have been diagnosed with the following conditions should consult their physician before using this service: Blockage of the arteries of the heart Heart valve problems Heart transplant Congestive heart failure Loss of consciousness If the patient has any of these conditions, LifeWatch will need to obtain authorization from their physician within 35 days of enrollment in the service. Warning: This device is not designed to be used with pacemakers or defibrillators. If the patient has either of these, the patient will not be allowed to enroll in the service. This device also cannot predict or diagnose a heart attack or be used for chest pain monitoring. Need for Signed Physician Agreement: Your agreement indicates you understand that LifeWatch (or affiliate) will contact your physician to verify in writing that you are their patient and that they are willing to be contacted in cases where there are clinically significant events involving your care. Your agreement indicates you understand that if written verification is not received from your physician within 35 days of your enrollment, you will not be able to utilize any aspects of the LifeWatch (or affiliate) service until such verification is received by LifeWatch (or affiliate). Your agreement certifies you understand that this service is not a substitute for physician care and that this is only a screening service.

Source page: https://510kreport.com/device/K012223
Methodology: https://510kreport.com/methodology