# K061123: Palm Ecg Recorder, Model EP-201/202

- Pathway: 510(k) (Traditional)
- Applicant: Parama-Tech Company., Ltd.
- Decided: Jun 29, 2007 after 431 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.
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)
- K042814: Readmyheart, Dailycare Biomedical, Inc. (2005) Summary page 1.
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801, Omron Healthcare, Inc. (2006). Cleared while this submission was under review Summary page 1.

## Indications for use
The Palm ECG Recordertm Model EP-201C/202C is intended for self-testing and home health care use. The Palm ECG Recordertm Model EP-201C/202C records, stores and transfers ECG waveforms, R-R graph and average heart rate data and presents these cardiological events in a synchronized time scale for interpretation by a physician trained in such an analysis. This is a prescription device for use only under the direction of a physician. A software user interface allows viewing. This screening tool is not intended for use as a diagnostic tool or as a substitute for a hospital diagnostic ECG device. This device is not intended for simultaneously recording and transmission of a user's ECG signal. This device is not recommended for use with implanted pacemakers.

Source page: https://510kreport.com/device/K061123
Methodology: https://510kreport.com/methodology