# K062894: Instantcheck RTD-Ecg Monitor, Model RMH4.0

- Pathway: 510(k) (Traditional)
- Applicant: Dailycare Biomedical, Inc.
- Decided: Feb 8, 2007 after 134 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). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 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.
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801, Omron Healthcare, Inc. (2006) Summary page 1.

## Most influential descendants
- K150869: Checkme Pro Health Monitor (2015), 5 descendants of its own
- K191088: Checkme O2 Pulse Oximeter (2019), 2 descendants of its own
- K242876: Pulse Oximeter ( PO2, PO2A, PO2B) (2025), 0 descendants of its own
- K213515: WesperO2 (2022), 0 descendants of its own
- K201635: MouthLab Vital Signs Monitoring System (2021), 0 descendants of its own

## Indications for use
The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. This device is intended for self-testing by adult users who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks. ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals. 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. The recorded data can be downloaded to Personal Computer via USB interface port.

Source page: https://510kreport.com/device/K062894
Methodology: https://510kreport.com/methodology