# K152863: Portable ECG Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical Systems Co.,Ltd
- Decided: Jun 22, 2016 after 266 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: 5 generations back to K963725 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112622: Handheld Ecg Monitor, Beijing Choice Electronic Technololgy Co., Ltd. (2012) Summary page 5.

## Indications for use
The Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate 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 Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.

Source page: https://510kreport.com/device/K152863
Methodology: https://510kreport.com/methodology