# K050620: Readmyheart, Model RMH3.0

- Pathway: 510(k) (Traditional)
- Applicant: Dailycare Biomedical, Inc.
- Decided: Jul 14, 2005 after 126 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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). 3 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042814: Readmyheart, Dailycare Biomedical, Inc. (2005) Summary page 1.

## Most influential descendants
- K083229: E.S Teck ( Electro Sensor Teck) (2009), 5 descendants of its own
- K102442: E.S.O. (Electro Sensor Oxi) (2010), 4 descendants of its own
- K160956: LD-Oxi system (2016), 2 descendants of its own
- K123130: Answatch Wrist Monitor Model TS-0411 (2013), 2 descendants of its own
- K200141: Oxi-W System (2020), 1 descendant of its own

## Indications for use
The device is a personal single lead Electrocardiograph monitor for home health care use. The device is intended for self-testing by users who might experience transient symptoms that may suggest cardiac conduction abnormity or by users whenever desired as routine recordings for daily home health care from Lead I ECG signal. ECG acquisition and transmission is voluntary and mutually activated by the user and the intended users are adults above 20 years old. The user is normally not required to apply electrode on body. Two electrodes integrated within the device are provided. The user has to press his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary external electrode provided separately if thumb pressing is not convenient for reason. It is highly recommended to use auxiliary external electrode for HRV analysis. The recorded data can be downloaded to Personal Computer via USB interface port. This device is not intended for use as precisely diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The device detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.

Source page: https://510kreport.com/device/K050620
Methodology: https://510kreport.com/methodology