# K193415: physIQ Heart Rhythm and Respiration Module

- Pathway: 510(k) (Traditional)
- Applicant: Physiq, Inc.
- Decided: Jun 11, 2020 after 185 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: 10 generations back to K962603 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183322: physIQ Heart Rhythm and Respiratory Module, Physiq, Inc. (2019) Summary page 4.

## Indications for use
The physIQ Heart Rhythm and Respiration Module (Version 3.0) 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 is intended to be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display). The physIQ Heart Rhythm and Respiration Module may only be used with FDA-cleared, chest-worn biosensors using “wet electrode” technology that capture single-lead digital ECG data at 125Hz or higher and integrated triaxial accelerometer data at 15Hz or higher and that are recorded in a compatible format for analysis. 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/K193415
Methodology: https://510kreport.com/methodology