# K113485: Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Carewell Electronics Co., Ltd.
- Decided: Apr 25, 2012 after 154 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: 6 generations back to K921669 (1993). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101876: Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010, Shenzhen Biocare Electronics Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K131900: Contec Electrocardiograph (2014), 1 descendant of its own
- K180432: AI-ECG Platform (2018), 0 descendants of its own
- K171360: CONTEC™ Electrocardiograph (2018), 0 descendants of its own

## Indications for use
Electrocardiographs, ECG-I1OIGQ), ECG-1103G(l), ECG-IlO3LW(I), ECG-1106L, ECG-1112 and ECG-11I12D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection, Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Source page: https://510kreport.com/device/K113485
Methodology: https://510kreport.com/methodology