# K063609: River- 1 Electrocardiograph (Ecg) Recorder and Transmitter

- Pathway: 510(k) (Traditional)
- Applicant: Shl Telemedicine International, Ltd.
- Decided: Sep 12, 2007 after 282 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: 3 generations back to K963725 (1997). 9 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020825: King of Hearts Express + AF Monitor, Card Guard Scientific Survival, Ltd. (2002) Summary page 1.
- K040942: VST3, Biowatch Medical, Inc. (2004) Summary page 1.
- K972649: Cardiocall Cardiac Event Recorder, Reynolds Medical, Ltd. (1997) Summary page 1.

## Most influential descendants
- K080047: Cardiosen'c (2008), 11 descendants of its own
- K113514: Smartheart (2012), 10 descendants of its own
- K142476: Master Caution Device MCD (2015), 6 descendants of its own
- K161431: SimplECG (2016), 5 descendants of its own
- K091579: Foresee Home (2009), 4 descendants of its own

## Indications for use
The River-1 is indicated for the evaluation of patients who experience transient symptoms such as dizziness, palpitations, syncope, or chest pain that might suggest arrhythmia. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once the data is recorded, the patient transmits this ECG data over the telephone or cellular network to a remote central receiving station to be reviewed by a healthcare professional.

Source page: https://510kreport.com/device/K063609
Methodology: https://510kreport.com/methodology