Data / Medical devices / United States / VivaQuant, Inc
VivaQuant, Inc: FDA-registered device maker in Arden Hills, MN, United States, 4 510(k) clearances
VivaQuant, Inc is registered with the FDA (registration 3011937459) in Arden Hills, MN, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011937459
- Address
- 1265 Grey Fox Rd Suite 400, Arden Hills, MN, United States, 55112
- Owner or operator
- VivaQuant, Inc (10059945)
- Roles
- Manufacturer
- First device listed
- March 13, 2019
- Registered through
- 2026
- Brand names listed
- RX-1 Rhythm Express Remote Cardiac Monitoring System, RX-1 Sleep, RX-1 mini, RX-1 mini Rhythm Express Remote Cardiac Monitoring System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Manufacturer | accessdata.fda.gov |
| Outpatient Cardiac Telemetry | QYX | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 22, 2026 | K253148 | RX-1 Sleep | MNR | Substantially Equivalent | Vivaquant, Inc. Dba Rhythm Express | accessdata.fda.gov |
| July 11, 2025 | K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | QYX | Substantially Equivalent | VivaQuant, Inc. | accessdata.fda.gov |
| September 2, 2020 | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | MLO | Substantially Equivalent | VivaQuant, Inc. | accessdata.fda.gov |
| February 16, 2019 | K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring System | DXH | Substantially Equivalent | VivaQuant, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilatory Effort Recorder
- All makers of Outpatient Cardiac Telemetry
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
- All makers of Detector And Alarm, Arrhythmia
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
Updated June 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.