# K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini)

- Pathway: 510(k) (Traditional)
- Applicant: Epi Mobile Health Solutions (S) Pte, Ltd.
- Decided: Jun 25, 2013 after 386 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- 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). 12 ancestors in all.
31 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111438: REKA E100, Reka Pte, Ltd. (2011) Summary page 2.
- K071228: Fidelity 200 Cardiac Event Recorder, Signalife, Inc. (2007) Summary page 2.

## Most influential descendants
- 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
- K190593: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (2019), 4 descendants of its own

## Indications for use
The EPI Mini Portable ECG Recorder (“EPI Mini”) is intended for use with a patient’s smartphone to record, store and wirelessly transmit physiological data to a remote server. It is indicated for individuals who are at risk for cardiac disease, experience transient symptoms suggesting possible cardiac arrthythmia or have existing heart conditions. The device can function as an Rx product when prescribed by and used under the supervision of a physician for the purpose of monitoring a patient’s ECG data. It is not a diagnostic device. The EPI Mini is intended for use by adults who suffer from cardio-vascular disease, are considered high risk for possible cardiovascular events or are concemned about their heart function and rhythm.

Source page: https://510kreport.com/device/K121628
Methodology: https://510kreport.com/methodology