# K111159: Heartcheck Pen Handheld Ecg with Gems Home

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocomm Solutions, Inc.
- Decided: Dec 22, 2011 after 241 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). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 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.
- K052303: Readmyheart, Model RMH2.0, Dailycare Biomedical, Inc. (2005) Summary page 2.

## Most influential descendants
- K181310: HeartCheck  Cardi Beat ECG Monitor with GEMS Mobile (2019), 0 descendants of its own
- K121009: Heartcheck Ecg Pen with Gems Home (2012), 0 descendants of its own

## Indications for use
The HeartCheckTM Pen Handheld with GEMS Home software is an over-the-counter device intended to record, store, transfer single channel Heart Rhythm signals and, for users under a physician's care, display Heart Rhythm waveforms. The HeartCheckTM Pen Handheld device along with GEMS Home software is not intended to substitute a hospital diagnostic ECG device. The device is not intended for simultaneously recording and transmitting a user's Heart Rhythm. Users with an implanted pacemaker or a defibrillator are not recommended to use this device. GEMS Home is a simple software user interface for managing Heart Rhythm recordings and associated data.

Source page: https://510kreport.com/device/K111159
Methodology: https://510kreport.com/methodology