# K093872: Handheld Ecg Monitor, Model MD100

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Mar 31, 2010 after 104 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: 2 generations back to K992696 (1999). 2 ancestors in all.
37 later devices descend from it; 4 cite it directly.
0 of 40 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.

## Most influential descendants
- K111438: REKA E100 (2011), 32 descendants of its own
- K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini) (2013), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own
- K181502: Zio AT ECG Monitoring System, ZEUS System (2018), 12 descendants of its own

## Indications for use
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for hospital. or home health care use, which can detect, display and store EGG signal, and if possible, provide average heart rate message after ECG measurement. The users can uise it themselves to check their heart condition. It is suitable for the adult users, 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. The product is not a conventional diagnostic tool.

Source page: https://510kreport.com/device/K093872
Methodology: https://510kreport.com/methodology