# K083535: Heartrak Smart Ecat

- Pathway: 510(k) (Traditional)
- Applicant: Universal Medical, Inc.
- Decided: Dec 15, 2008 after 17 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: 4 generations back to K963725 (1997). 11 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071130: Heartrak AF, Universal Medical, Inc. (2008) Summary page 2.
- K060911: CG-6108 Arrhythmia Ecg Event Recorder, Card Guard Scientific Survival, Ltd. (2006) Summary page 2.

## Most influential descendants
- K131699: Emotion Ecg Mobile (2013), 16 descendants of its own
- K141813: Rhythmstar System (2014), 8 descendants of its own
- K143032: eMotion Faros ECG Mobile (2015), 6 descendants of its own
- K161431: SimplECG (2016), 5 descendants of its own
- K201669: SimpleSENSE (2020), 3 descendants of its own

## Indications for use
Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of a compatible RF receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center. Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.

Source page: https://510kreport.com/device/K083535
Methodology: https://510kreport.com/methodology