Data / Medical devices / United States / Infobionic, Inc.
Infobionic, Inc.: FDA-registered device maker in Burleson, TX, United States, 4 510(k) clearances
Infobionic, Inc. is registered with the FDA (registration 3010112812) in Burleson, TX, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010112812
- Address
- 820 SW Wilshire Blvd, Burleson, TX, United States, 76028
- Owner or operator
- InfoBionic, Inc. (10051518)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 31, 2016
- Registered through
- 2026
- Brand names listed
- MoMe ARC, MoMe ARC Wireless Ambulatory ECG Monitoring and Detection System, MoMe Kardia, MoMe Software Platform
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Outpatient Cardiac Telemetry | QYX | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 29, 2025 | K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | DSI | Substantially Equivalent | Infobionic, Inc. | accessdata.fda.gov |
| October 6, 2023 | K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | DSI | Substantially Equivalent | Infobionic, Inc. | accessdata.fda.gov |
| March 11, 2016 | K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | QYX | Substantially Equivalent | Infobionic, Inc. | accessdata.fda.gov |
| December 17, 2015 | K152491 | MoMe Software Platform | DSI | Substantially Equivalent | Infobionic, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 29, 2025. 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.