RX-1 Rhythm Express Remote Cardiac Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183704 FDA 510(k)
- FDA Product Code
- DXH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2920 FDA 510(k)
- Regulation Number
- 870.2920 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RX-1 Rhythm Express Remote Cardiac Monitoring System is a transmitter and receiver device designed for electrocardiograph monitoring via telephone. Classified as a Class II medical device, it is intended for continuous remote cardiac monitoring of patients weighing over 10 kg who have or are at risk of cardiac disease, or exhibit intermittent symptoms requiring ongoing monitoring. The system records ECG data and employs an analysis algorithm to detect arrhythmias, including P-wave abnormalities, for clinical assessment.
This system is supplied as a reusable, non-sterile device intended for use in clinical and home settings. It operates wirelessly and transmits ECG data for remote review, with no MRI safety restrictions specified. The device requires proper storage in a dry environment and is authorized under FDA 510(k) clearance (K183704). Multiple FEI numbers (e.g., 3013689228) correspond to its regulatory registration, and it falls under the product code DXH for transmitters and receivers.
Frequently asked questions
What is the RX-1 Rhythm Express Remote Cardiac Monitoring System used for?
The RX-1 Rhythm Express Remote Cardiac Monitoring System is designed for continuous remote monitoring of patients weighing over 10 kg who have cardiac disease, are at risk of cardiac issues, or experience intermittent symptoms requiring ongoing assessment. It records ECG data and uses an algorithm to detect arrhythmias, including P-wave abnormalities, enabling clinicians to evaluate cardiac health remotely.
Is the RX-1 system reusable or single-use?
The RX-1 Rhythm Express Remote Cardiac Monitoring System is supplied as a reusable device. It is intended for repeated use in both clinical and home settings, provided it is properly maintained and stored. Reusability is supported by its non-sterile classification, which is suitable for environments where sterilization is not required.
What storage conditions are required for the RX-1 system?
The RX-1 system must be stored in a dry environment to ensure proper functionality and longevity. Avoiding moisture exposure is critical, as it could potentially damage the wireless components or affect the device’s performance. Always follow manufacturer guidelines for optimal storage practices.
Can the RX-1 system be used with MRI equipment?
The RX-1 Rhythm Express Remote Cardiac Monitoring System does not have specified MRI safety restrictions mentioned in its documentation. However, it is always recommended to consult the manufacturer’s guidelines or safety data sheets for the most accurate and up-to-date information regarding MRI compatibility, as wireless devices may pose risks in MRI environments.
What regulatory approvals does the RX-1 system hold?
The RX-1 Rhythm Express Remote Cardiac Monitoring System holds FDA 510(k) clearance under the reference number K183704. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for Class II medical devices in the United States. Always verify the latest regulatory status with the manufacturer or official databases.
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: Cardiac Monitoring & ECG Solutions | Rhythm Express, VIVAQUANT RHYTHM EXPRESS RX-1 MINI USE MANUAL Pdf Download, PDF Rhythm Express® RX-1 mini Remote Cardiac Monitoring System, VIVAQUANT RHYTHM EXPRESS RX-1 USER MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183704 | Class II | Active |
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Manufacturer
- Manufacturer
- VivaQuant, Inc.
Sources (1)
- FDA 510(k) K183704 24 fields · synced Oct 5, 2026