FDA.reportPublic FDA data

INFOBIONIC, INC.

Matched from indexed company URL: Infobionic, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101128123010112812INFOBIONIC, INC.1N2026-01-01321 Billerica Rd Office Link #5 Chelmsford MA US 01824

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B690MA10MoMe® ARC - MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in theirdiagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock withaccessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gatewayusing a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to theMoMe® Software Platform (K152491) over a 4G LTE cellular link.The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gatewaybattery being wirelessly charged by the charging dock and the sensor battery being wirelesslycharged by Gateway.617-755-6602dmaccutcheon@infobionic.com
B690MA20MoMe® ARC - The MoMe ARC® device consists of a Sensor Pod, Leads, Gateway, and Charging Cradle withaccessories. The body worn Sensor Pod acquires, stores and forwards electrocardiogram(ECG) data from Leads in a Wired Lead-Set or in a Patch to the Gateway using a 2.4GHz BLEwireless link. The Gateway consists of an OTS mobile device running the MoMe ARC® GatewayMobile App. The Gateway is a Medical Device Data System (MDDS) which stores and forwardsthe ECG signal data to the MoMe Software Platform (K152491) via a wireless cellular link.The MoMe ARC® communicates with the MoMe Software Platform (K152491), a web-basedremote server software with proprietary algorithms for analysis, using the MoMe DeviceCommunications Protocol. The MoMe Software System (K152491) analyzes the data via theembedded algorithm and, when indicated, data identified by the algorithm is flagged forphysician review.Once activated and operating normally, the system requires no patient intervention to capture oranalyze data. However, the MoMe ARC® has an optional patient triggered event feature thatallows for manual selection and recording of patient symptoms, if and when desired.The device is intended for use under prescription only (Rx only) for monitoring patients withsuspected cardiac arrhythmias.707-694-4905lleal@infobionic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1929101460133881K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI2025-07-29
1929101118417737K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI2023-10-06
1929101741724075K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX2016-03-11
1929101680624556K152491MoMe Software PlatformDSI2015-12-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSI32025-07-29
QYX12016-03-11

PMN#

GUDID#

MoMe® ARC - The MoMe ARC® device consists of a Sensor Pod, Leads, Gateway, and Charging Cradle withaccessories. The body worn Sensor Pod acquires, stores and forwards electrocardiogram(ECG) data from Leads in a Wired Lead-Set or in a Patch to the Gateway using a 2.4GHz BLEwireless link. The Gateway consists of an OTS mobile device running the MoMe ARC® GatewayMobile App. The Gateway is a Medical Device Data System (MDDS) which stores and forwardsthe ECG signal data to the MoMe Software Platform (K152491) via a wireless cellular link.The MoMe ARC® communicates with the MoMe Software Platform (K152491), a web-basedremote server software with proprietary algorithms for analysis, using the MoMe DeviceCommunications Protocol. The MoMe Software System (K152491) analyzes the data via theembedded algorithm and, when indicated, data identified by the algorithm is flagged forphysician review.Once activated and operating normally, the system requires no patient intervention to capture oranalyze data. However, the MoMe ARC® has an optional patient triggered event feature thatallows for manual selection and recording of patient symptoms, if and when desired.The device is intended for use under prescription only (Rx only) for monitoring patients withsuspected cardiac arrhythmias.

Infobionic, Inc.

2025-08-25

MoMe® ARC - MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in theirdiagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock withaccessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gatewayusing a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to theMoMe® Software Platform (K152491) over a 4G LTE cellular link.The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gatewaybattery being wirelessly charged by the charging dock and the sensor battery being wirelesslycharged by Gateway.

Infobionic, Inc.

2023-12-28

MoMe® Kardia - MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.

Infobionic, Inc.

2018-09-23

MoMe® Software Platform - MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

Infobionic, Inc.

2018-09-23