# K963725: Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard, Ltd.
- Decided: Sep 10, 1997 after 415 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.
210 later devices descend from it; 5 cite it directly.
0 of 211 devices 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.

## Most influential descendants
- K012223: CG-2211 Selfcheck Ecg Transmitter (2001), 181 descendants of its own
- K042254: PMP4 Selfcheck Ecg (2005), 99 descendants of its own
- K012012: Ecg Home (2002), 60 descendants of its own
- K042814: Readmyheart (2005), 59 descendants of its own
- K052767: Afibalert Atrial Fibrillation Detector (2006), 47 descendants of its own

## Indications for use
This device intended for use by patients who experience transient symptoms that may suggest cardiac arthythmia. The device is not intended for the simultaneous recording and transmitting of the patient’s ECQ signals.

Source page: https://510kreport.com/device/K963725
Methodology: https://510kreport.com/methodology