MoMe® Software Platform
MoMe Software Platform receives and analyses ECG recordings to support physicians assessing cardiac arrhythmias in patients aged 22 years and older. It accepts continuous single- or…
MoMe Software Platform receives and analyses ECG recordings to support physicians assessing cardiac arrhythmias in patients aged 22 years and older. It accepts continuous single- or multiple-lead ECG data from recorders that follow its specified communication protocol, using a network or internet connection.
An arrhythmia-analysis algorithm identifies events selected for physician review. Web and mobile applications show recordings, events and reports, including arrhythmia duration, activity, heart-rate variability and patient-reported symptoms. The platform supports Holter, event-monitoring and mobile cardiac telemetry modes.
Listed Item
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.
Clinical Scope
The platform is not an emergency service. It is contraindicated for patients needing inpatient monitoring for potentially life-threatening arrhythmias, those the physician believes require hospitalization, and patients with implanted pacemakers, defibrillators, neurostimulators or body-worn medical devices such as insulin pumps. Results inform assessment alongside symptoms and other tests.
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) | K152491 |
| Record published | 2018-09-23 |
| Record revised | 2023-11-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1400 | 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.