# K231424: HeartBeam AIMIGo (TM) System

- Pathway: 510(k) (Traditional)
- Applicant: Heartbeam, Inc.
- Decided: Dec 13, 2024 after 576 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K963725 (1997). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210753: KardiaMobile 6L, AliveCor, Inc. (2021) Summary page 6.

## Indications for use
The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

Source page: https://510kreport.com/device/K231424
Methodology: https://510kreport.com/methodology