Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

K-Number: K250356 · 2025-07-29

ApplicantInfobionic, Inc.
Decision Date2025-07-29
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) is a medical device manufactured by Infobionic, Inc.. It received FDA 510(k) clearance on 2025-07-29 under approval number K250356. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)?

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) is a medical device that received FDA 510(k) clearance on 2025-07-29. It is manufactured by Infobionic, Inc.. The 510(k) number is K250356.

When was MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) approved by the FDA?

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) received FDA 510(k) clearance on 2025-07-29, under approval number K250356.

What company makes MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)?

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) is manufactured by Infobionic, Inc..

What is the FDA product code for MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)?

The FDA product code for MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) is DSI.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT01220349 Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy COMPLETED NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41694722 Lessons from global materiovigilance systems: What India can learn? Perspectives in clinical research (2026)

Other Devices by Infobionic, Inc.

K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

Related Devices (Code: DSI)

K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC K153477EMMa Electronic Monitoring ManagementVitasystems GmbH K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation K151835Vital Signs Patch SystemLifewatch Technologies , Ltd. K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑