Cardiovascular · 510(k) · 2020
RX-1 Rhythm Express Remote Cardiac Monitoring System
VivaQuant Inc.. Cleared by FDA on 2 September 2020 under submission K200833, product code MLO (electrocardiograph, ambulatory, with analysis algorithm). What FDA's record says, in FDA's words.
Device record · K200833
- Device. RX-1 Rhythm Express Remote Cardiac Monitoring SystemDEVICE
- Company. VivaQuant Inc.COMPANY
- Decision. 2 September 2020, 510(k), substantially equivalent (traditional review); received 30 March 2020DECISION
- Panel. CardiovascularPANEL
- Product code. MLO, Electrocardiograph, Ambulatory, With Analysis AlgorithmCODE
- Regulation. 21 CFR 870.2800, Class IIREG
- Source. FDA database entry · decision document (12 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 Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented for review by a medical professional. The data received from the Rhythm Express device can be used by another device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The Rhythm Express system communicates events from the patient to the monitoring center within one to seven minutes (assuming cell service is available) and hence is not suitable for use as a real-time arrhythmia event monitor.
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
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 24 reports filed against devices carrying product code MLO. 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 · HScribe · BAXTER HEALTHCARE CORPORATION · report 3006087789-2026-00026
30 July 2026 · Malfunction · SOFTWARE HSCRIBE · BAXTER HEALTHCARE CORPORATION · report 1316463-2026-00325
13 February 2026 · Malfunction · CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWARE · MORTARA INSTRUMENT · report 2183461-2026-00001
THE CUSTOMER REPORTED THAT THEY HAD A PATIENT APPEARING TWICE IN HSCRIBE WITH EXACTLY THE SAME NAME, NHS NUMBER, DATE OF BIRTH, AND SETUP TIMESTAMP (SAME DAY, HOUR, MINUTE, AND SECOND). HOWEVER, WHEN OPENING EACH RECORD, THE ECG TRACES WERE COMPLETELY DIFFERENT AND CLEARLY CORRESPOND TO TWO DIFFERENT PATIENTS. THERE WAS NO ADVERSE EVENT REPORTED.
25 October 2025 · Malfunction · RX-1 MINI RHYTHM EXPRESS REMOTE CARDIAC MONITORING SYSTEM · VIVAQUANT, INC · report 3011937459-2025-03527
IBC FROM PATIENT DUE TO DEVICE NOT LIGHTING UP INDICATING A CHARGE, TRIED SOFT RESET AND DEVICE ISN'T VIBRATING OR LIGHTING UP. DEVICE IS UNRESPONSIVE AND PATIENT STATED THAT EARLY THIS MORNING THE HOUSING OF THE DEVICE STARTED TO GET VERY HOT AND NOW HE HAS A BLISTER UNDER WHERE THE HOUSING WAS SITTING ON HIS CHEST.
7 August 2025 · Injury · BODYGUARDIAN MINI - REMOTE CARDIAC MONITOR · BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. · report MW5174152
MY NAME IS (B)(6). FIRST, I WANT TO MAKE IT CLEAR I AM OUT TO TRASH BOSTON SCIENTIFIC BUT A COMPANY LIKE BOSTON SCIENTIFIC SHOULD KNOW BETTER BECAUSE PEOPLE DIE EVERYDAY FROM ALLERGIC REACTIONS. THE BODYGUARD MINI THE HEART MONITOR FROM BOSTON SCIENTIFIC COME IN A BLUE WHITE BOX THE DEVICE AND THE GLUE STRIPS YOU PLACE IT ON CHEST TO HOLD THE DEVICE, IT WAS ON ME FOR 2 WEEKS WHEN I REMOVE THE DEVICE I SCREAM RUNNING OUT OF MY ROOM I REACH OUT TO BOSTON SCIENTIFIC TOLD THEM WHAT HAPPEN THEY […]
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 MLO, in Cardiovascular, from VivaQuant Inc., or cleared in 2020. 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.