MoMe® ARC
MoMe ARC is a wireless ambulatory ECG monitoring system designed to aid physicians in diagnosing cardiac arrhythmias in patients with a demonstrated need for monitoring. The FDA summary…
MoMe ARC is a wireless ambulatory ECG monitoring system designed to aid physicians in diagnosing cardiac arrhythmias in patients with a demonstrated need for monitoring. The FDA summary identifies a body-worn sensor, gateway and charging dock as its primary components.
The sensor acquires and forwards ECG data to the gateway, which communicates with the MoMe software system for analysis. The stated scope is ECG reporting and arrhythmia detection in patients with non-life-threatening arrhythmias; the filing says it is not an emergency service.
Listed Item
The MoMe ARC® device consists of a Sensor Pod, Leads, Gateway, and Charging Cradle with accessories. 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 BLE wireless link. The Gateway consists of an OTS mobile device running the MoMe ARC® Gateway Mobile App. The Gateway is a Medical Device Data System (MDDS) which stores and forwards the 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-based remote server software with proprietary algorithms for analysis, using the MoMe Device Communications Protocol. The MoMe Software System (K152491) analyzes the data via the embedded algorithm and, when indicated, data identified by the algorithm is flagged for physician review. Once activated and operating normally, the system requires no patient intervention to capture or analyze data. However, the MoMe ARC® has an optional patient triggered event feature that allows 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 with suspected cardiac arrhythmias.
Data Collection
The system captures ECG data without patient intervention during normal use, while its event feature allows patient-triggered symptom recording. The filing describes the output as adjunctive and says the system is not an emergency service.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shandong Corecare Technology Limited | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | Infobionic, Inc., United States |
|---|---|
| FDA product code | DSI |
| Device type | Detector And Alarm, Arrhythmia |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K230265 |
| Record published | 2023-12-28 |
| Record revised | 2024-01-05 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 50 °C; Storage environment humidity 0 to 93 % RH |
| Distribution end date | 2031-08-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30000 | In distribution | |
| 32000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulink | Spacelabs Healthcare (Washington), Inc | 160 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 30 |
| Q-Tel RMS | Mortara Instrument, Inc. | 20 |
| Detector And Alarm, Arrhythmia | Philips Medical Systems Hsg | 20 |
| ECG Electrodes | Philips Medical Systems Hsg | 19 |
| Seeq™ | Medtronic, Inc. | 18 |
| Life Sensing Instruments, Inc. | Life Sensing Instruments, Inc. | 17 |
| NIBP Cuffs | Philips Medical Systems Hsg | 14 |
| Waveline EZ+ | Avante | 11 |
| BodyGuardian | Preventice Technologies, Inc. | 10 |
| BodyGuardian Kit | Preventice Technologies, Inc. | 8 |
| Waveline Pro+ | Avante | 7 |
Showing 12 of 112. All products under Detector And Alarm, Arrhythmia
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250356 | 2025-07-29 |
| K230265 | 2023-10-06 |
| K152491 | 2015-12-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.