# Infobionic, Inc.

- Location (FDA's records): Lowell, MA
- FDA decisions: 5 (2014–2025): 5 510(k) clearances
- Product codes: DSI (3), QYX (2)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cardionet, Inc.: 2 (https://510kreport.com/company/cardionet)
- Braemar Manufacturing, LLC: 1 (https://510kreport.com/company/braemar-manufacturing)
- Biomedical Systems Corp.: 1 (https://510kreport.com/company/biomedical-systems)
- Preventice: 1 (https://510kreport.com/company/preventice)

## Firms that cite its devices most
- Smartcardia SA: 1 (https://510kreport.com/company/smartcardia)

## Its most-cited devices
- K160064: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (2016), cited by 2
- K230265: MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (2023), cited by 1
- K133753: Mome Ecg Continuous Detection and Arrhythmia Detector (2014), cited by 1

## Recent decisions
- K250356: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (Jul 29, 2025)
- K230265: MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (Oct 6, 2023)
- K160064: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (Mar 11, 2016)
- K152491: MoMe Software Platform (Dec 17, 2015)
- K133753: Mome Ecg Continuous Detection and Arrhythmia Detector (Sep 19, 2014)

Source page: https://510kreport.com/company/infobionic