# K121009: Heartcheck Ecg Pen with Gems Home

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocomm Solutions, Inc.
- Decided: May 17, 2012 after 44 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093872: Handheld Ecg Monitor, Model MD100, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 2.
- K111159: Heartcheck Pen Handheld Ecg with Gems Home, Cardiocomm Solutions, Inc. (2011)

## Indications for use
The HeartCheck ECU Pen with GEMS Home is a teleniedicine based solution that is intended to enable adult patients to record, store, transfer and display single channel ECG waveforms while involved in everyday activities anywhere. The HeartCheck ECG Pen combined with GEMS Home enables the person to send their EGG recordings to a medical service for review and interpretation by a qualified health service professional such as a physician. GEMS Home use is not intended to substitute for a hospital. diagnostic ECU test. The software and hardware are not intended for recording and transmission of user's EGG signal simultaneously. Patients with implanted pacemaker or defibrillator are not recommended to use this device. GEMS Home is a simple software user interface with ECU trace viewing function.

Source page: https://510kreport.com/device/K121009
Methodology: https://510kreport.com/methodology