# K131572: Micro Ambulatory Ecg Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Dimetek Digital Medical Technologies, Ltd.
- Decided: Jul 22, 2013 after 52 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 K950944 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K101569: V-Trust Model TD-2202 Portable Ecg Recorder, Taidoc Technology Corporation (2011) Summary page 1.

## Indications for use
Dimetek Micro Ambulatory ECG Recorder Is intended for EGG detecting, recording and playback by adult patients who are concerned about their heart rhythm. It is used both In the clinics and home care environment. User can choose the monitor mode and event mode to record the ECG data when feeling any heart condition occur. The device allows user to record their ECG data in TF card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia. The EGG data in TF card can be downloaded to PC, and be read by EGG viewer software. The device Is NOT designed or intended for medical diagnosis.

Source page: https://510kreport.com/device/K131572
Methodology: https://510kreport.com/methodology