# K112622: Handheld Ecg Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Jul 19, 2012 after 315 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.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052303: Readmyheart, Model RMH2.0, Dailycare Biomedical, Inc. (2005) Summary page 2.

## Most influential descendants
- K152863: Portable ECG Monitor (2016), 0 descendants of its own

## Indications for use
The Handheld ECG Monitor OTC version is intended to record and store Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Handheld ECG Monitor OTC version has simple user interface without ECG trace viewing function.

Source page: https://510kreport.com/device/K112622
Methodology: https://510kreport.com/methodology