Cardiovascular · 510(k) · 2019
physIQ Heart Rhythm and Respiratory Module
physIQ, Inc. Cleared by FDA on 10 July 2019 under submission K183322, product code DPS (electrocardiograph). What FDA's record says, in FDA's words.
Device record · K183322
- Device. physIQ Heart Rhythm and Respiratory ModuleDEVICE
- Company. physIQ, IncCOMPANY
- Decision. 10 July 2019, 510(k), substantially equivalent (traditional review); received 30 November 2018DECISION
- Panel. CardiovascularPANEL
- Product code. DPS, ElectrocardiographCODE
- Regulation. 21 CFR 870.2340, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 898 reports filed against devices carrying product code DPS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · DECGPageWriter TC S · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-102027
25 September 2026 · Malfunction · PageWriter · Philips Medical Systems · report 1218950-2026-100667
18 September 2026 · Malfunction · Q-Stress · BAXTER HEALTHCARE CORPORATION · report 3006087789-2026-00025
Baxter received a report stating that an exam was done earlier under the wrong patient information. This occurred after patient use. There was no patient injury or death reported with this event.
16 September 2026 · Malfunction · Midmark Digital ECG Plug-In Software Version 10.2.2 · Midmark Corporation · report 1523530-2026-00012
It was reported by 15 customers that they were getting a high heart rate on the ECG. The ECG did not calculate the heart rate correctly due to multiple instances of the ECG Plug-in being opened concurrently. The doctor reviewed the results and no medication was given or harm occurred. The customers were sent the firmware update as they were on the old firmware Plug-in version.
16 September 2026 · Malfunction · Cardiac Workstation · Philips Medizin Systeme Böblingen GmbH · report 9610816-2026-101917
It was reported that the heart rate reading is inaccurate. It is unknown if the device was in use on a patient. There was no report of patient or user harm.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DPS, in Cardiovascular, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.