MoMe® ARC

Primary DI
B690MA10
Brand
MoMe® ARC
Company
Infobionic, Inc.
Model
30000
Device description
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.
Published
2023-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSIDetector And Alarm, Arrhythmia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230265000MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.2023-10-06DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B690MA10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electrocardiographic, telemetricA small unit dedicated for the receipt of wireless electrocardiogram (ECG) signals sent from an ambulatory patient so that the electrical activity of the patient's heart can be monitored when the patient is remote to the patient monitoring system. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG signal information received and provided by this module.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617-755-6602dmaccutcheon@infobionic.com

Regulatory Flags#

DUNS number
078650138
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B690MA20MoMe® ARC320002025-08-25
B690MK10MoMe® Kardia 018542018-09-23
B690MS10MoMe® Software Platform14002018-09-23

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