# K183322: physIQ Heart Rhythm and Respiratory Module

- Pathway: 510(k) (Traditional)
- Applicant: Physiq, Inc.
- Decided: Jul 10, 2019 after 222 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: 9 generations back to K962603 (1997). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180234: physiQ Heart Rhythm Module, Physiq, Inc. (2018) Summary page 4.
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch, Vitalconnect, Inc. (2015) Summary page 4.

## Most influential descendants
- K193415: physIQ Heart Rhythm and Respiration Module (2020), 0 descendants of its own

## Indications for use
The physIQ Heart Rhythm and Respiration Module (Version 2.0) is intended for use by a physician or other qualified medical professionals for the calculation of heart rate and heart rate variability, the detection of atrial fibrillation and determination of respiration rate using ambulatory ECG and triaxial accelerometer data. The physIQ Heart Rhythm and Respiration Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using “wet” electrode technology and triaxial accelerometers when assessment of rhythm and respiration rate is desired. The physIQ Heart Rhythm and Respiration Module is for use in adult patients in subacute clinical and nonclinical settings for remote patient monitoring. The physIQ Heart Rhythm and Respiration Module is not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.

Source page: https://510kreport.com/device/K183322
Methodology: https://510kreport.com/methodology