# K180234: physiQ Heart Rhythm Module

- Pathway: 510(k) (Traditional)
- Applicant: Physiq, Inc.
- Decided: Aug 10, 2018 after 193 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 K003621 (2000). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0, Monebo Technologies, Inc. (2007) Summary page 4.

## Most influential descendants
- K192004: Eko Analysis Software (2020), 4 descendants of its own
- K213794: Eko Murmur Analysis Software (EMAS) (2022), 3 descendants of its own
- K240901: Stethophone (2024), 1 descendant of its own
- K183322: physIQ Heart Rhythm and Respiratory Module (2019), 1 descendant of its own
- K252595: Stethophone Pro (2025), 0 descendants of its own

## Indications for use
The physlQ Heart Rhythm Module is intended for use by a physician or other qualified medical professionals for the calculation of heart rate and heart rate variability and the detection of atrial fibrillation using ambulatory ECG data. The physlQ Heart Rhythm Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology when assessment of rhythm is desired. The physlQ Heart Rhythm Module is for use in subacute clinical and non-clinical settings for remote patient monitoring. The physlQ Heart Rhythm Module is not for use in patients requiring life-supporting or life-sustaining systems or ECG Alarm devices,

Source page: https://510kreport.com/device/K180234
Methodology: https://510kreport.com/methodology