MoMe® ARC

GUDID B690MA10

MoMe® ARC 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. The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link. The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway.

Infobionic, Inc.

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• Primary Device ID: B690MA10
• NIH Device Record Key: e55f7069-767f-4ec9-b65a-3f520430cad8
• Commercial Distribution Discontinuation: 2029-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MoMe® ARC
• Version Model Number: 30000
• Company DUNS: 078650138
• Company Name: Infobionic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com
• Phone: 617-755-6602
• Email: dmaccutcheon@infobionic.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B690MA10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230265

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-05
• Device Publish Date: 2023-12-28

Devices Manufactured by Infobionic, Inc.

• B690MA10 - MoMe® ARC: 2024-01-05MoMe® ARC 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. The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link. The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway.
• B690MA10 - MoMe® ARC: 2024-01-05 MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patie
• B690MK10 - MoMe® Kardia: 2019-05-07 MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in pa
• B690MS10 - MoMe® Software Platform: 2018-10-24 MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes