# K113234: Mobcardio System

- Pathway: 510(k) (Traditional)
- Applicant: Mobhealth Incorporation
- Decided: Nov 17, 2011 after 15 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 K002074 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051534: Cardioline AR 600, AR 1200, AR 2100, Et Medical Devices Spa (2005) Summary page 1.
- K103640: Midmark Iqecg, Brentwood Medical Technology Corp. (2011) Summary page 1.
- (no number) ARS-EKG 12K ECG System: named in the summary without a submission number
- (no number) Kardiosis Ltd. Electrocardiography System: named in the summary without a submission number

## Indications for use
The MobCardio System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult populations. The device is designed to collect, transmit, and display resting 12 lead EKG data. The clinical and diagnostic evaluation of acquired EKG signals should be made by a physician, who has experience or is specialized in Cardiology. No clinical interpretation of EKG is provided.

Source page: https://510kreport.com/device/K113234
Methodology: https://510kreport.com/methodology