# K012012: Ecg Home

- Pathway: 510(k) (Abbreviated)
- Applicant: H&C Medical Devices Spa
- Decided: Jan 17, 2002 after 203 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). 1 ancestor in all.
60 later devices descend from it; 1 cites it directly.
0 of 62 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 1.

## Most influential descendants
- K042814: Readmyheart (2005), 59 descendants of its own
- K052303: Readmyheart, Model RMH2.0 (2005), 38 descendants of its own
- K111438: REKA E100 (2011), 32 descendants of its own
- K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini) (2013), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own

## Indications for use
ecg@home is a personal single lead ECG transtelephonic transmitter. The device is intended for self-testing by patients by recording ten seconds of the first standard lead (D1) or of the second standard lead (D2) of the electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician. The patient is normally not required to apply electrodes on the body. Two electrodes integrated within the device are provided. The patient has to place his thumbs on the two integrated electrodes in order to record the ECG signal. In case of very low amplitude of lead D1 caused by heart orientation (mainly experienced by women), an external auxiliary electrode is provided in order to record lead D2. The recorded data can be directly trasmitted to a receiving station via a common phone line or can be downloaded via RS 232 serial digital port to a Personal Computer for subsequent connection to a Service Provider using Internet facilities.

Source page: https://510kreport.com/device/K012012
Methodology: https://510kreport.com/methodology