physIQ Heart Rhythm and Respiratory Module
FDA 510(k)Class II (US FDA 510(k))
by Physiq, Inc
Identifiers
- 510(k) Number
- K183322 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The physIQ Heart Rhythm and Respiratory Module is an assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location for viewing. It is intended for use by a physician or other qualified medical professionals for the calculation of heart rate variability, the detection of atrial fibrillation, and determination of respiration rate.
The module is designed to be integrated into a customer's existing end-to-end monitoring system and is compatible with FDA-cleared, chest-worn biosensors utilizing 'wet electrode' technology that capture single-lead digital ECG data and triaxial accelerometer data. It received FDA 510(k) clearance (K183322) on July 10, 2019, and is manufactured by physIQ, Inc. in Naperville, Illinois.
Frequently asked questions
What is the physIQ Heart Rhythm and Respiratory Module used for?
It is designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location for viewing, enabling calculation of heart rate variability, detection of atrial fibrillation, and determination of respiration rate by qualified medical professionals.
How is the physIQ Heart Rhythm and Respiratory Module supplied and integrated?
The module is designed to be integrated into a customer's existing end-to-end monitoring system and is compatible with FDA-cleared, chest-worn biosensors that use wet electrode technology to capture single-lead digital ECG and triaxial accelerometer data.
Is the physIQ Heart Rhythm and Respiratory Module sterile or single-use?
The device data does not specify sterility or single-use status; it is described as a module intended for integration into a monitoring system, suggesting it is a reusable component rather than a disposable or sterile single-use item.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: physIQ Heart Rhythm and Respiratory Module, physIQ Heart Rhythm and Respiration Module by physIQ, Inc | FDA 510 (k ..., DEVICE: physIQ Heart Rhythm and Respiration Module (00860004366256)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183322 | Class II | Active |
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Manufacturer
- Manufacturer
- Physiq, Inc
- FDA Applicant
- Physiq, Inc.
Sources (1)
- FDA 510(k) K183322 24 fields · synced Sep 25, 2026