# K073152: PC-180 / Prince 180 Easy Ecg Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Jan 10, 2008 after 63 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992696 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801, Omron Healthcare, Inc. (2006) Summary page 1.

## Indications for use
The device is a handheld, personal electrocardiograph (ECU) unit, which can measure electrical activities of the heart easily and conveniently. It's a single LEAD ECG measuring device for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition. It is suitable for the adult users (age 18 or older), who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references. This Device is also not intended for recording and transmission of user's ECG signal simultaneously, and it's not recommended to use with implanted pacemaker.

Source page: https://510kreport.com/device/K073152
Methodology: https://510kreport.com/methodology