# K172778: CheckMyHeart Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dailycare Biomedical, Inc.
- Decided: Jul 5, 2018 after 294 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: 4 generations back to K963725 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050620: Readmyheart, Model RMH3.0, Dailycare Biomedical, Inc. (2005) Summary page 4.

## Indications for use
CheckMyHeart Plus is intended to record, recall, store and transfer Lead I ECG signals for home health care use. The intended users are adults above 21 years old. This device is not intended to substitute for a hospital diagnostic ECG device. This device is also not intended for recording and transmission of user’s ECG signals simultaneously.

Source page: https://510kreport.com/device/K172778
Methodology: https://510kreport.com/methodology