# K111438: REKA E100

- Pathway: 510(k) (Abbreviated)
- Applicant: Reka Pte, Ltd.
- Decided: Sep 12, 2011 after 111 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). 8 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052303: Readmyheart, Model RMH2.0, Dailycare Biomedical, Inc. (2005) Summary page 1.
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801, Omron Healthcare, Inc. (2006) Summary page 1.
- K963811: Card Guard Model CG-6106 Personal Electrocardiogram (Ecg) Transmitter Device, Card Guard Scientific Survival, Ltd. (1996) Summary page 1.
- K093872: Handheld Ecg Monitor, Model MD100, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- 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
- K210822: DeepRhythmAI (2022), 6 descendants of its own

## Indications for use
The REKA E100 EGG Event Recorder (Cardiac Rhythm Monitor) is intended for use by patients who may be at risk for experiencing transient cardiac symptoms that could suggest cardiac arrhythmia. The device records the patients EGG on demand at any time the patient feels any physical symptoms indicative of a potential heart event. A 30 second single channel ECG isrecorded and transmitted to a monitoring center. The monitoring center provides the EGG data to the medical practitioner for evaluation. The Indications for Use are the same as the predicate devices. 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 home health care use, and which can record and store an EGG signal, and then transmit the EGG recording to a hospital or cardiology center for interpretation and review. It is suitable for adult users, who suffer from cardlo-vascular diseases, are considered at high risk for potential cardiovascular events or other adult people who are concerned about their heart function and rhythm as they move about during their daily life. This device is not intended for use as a conventional diagnostic tool, but is to be used as a healthcare patient evaluation tool which can provide a doctor with the recorded EGG data as a reference to help detect and analyze heart events that a patient may experience at any time or any place.

Source page: https://510kreport.com/device/K111438
Methodology: https://510kreport.com/methodology