EMMa Electronic Monitoring Management
510(k) K153477
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153477 | Date25 May 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The EMMa Electronic Monitoring Management is a server-side software medical device classified as a Detector and Alarm for Arrhythmia (product code DSI). It functions as a centralised platform for receiving, storing, and managing physiological ECG data transmitted wirelessly from ambulatory cardiac monitors, enabling continuous remote patient monitoring.
This device is designed for use in Telemonitoring Service Centres (TSC), where technicians configure remote monitoring devices, review transmitted ECG data, and generate reports. Supplied as software installed on a server, it operates as a reusable, non-sterile system. The device holds FDA 510(k) clearance (K153477) under the traditional review pathway and falls under Class II regulatory classification with special controls.
Other devices from Vitasystems GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the EMMa Electronic Monitoring Management used for?
The EMMa Electronic Monitoring Management is a server-side software device designed specifically for Telemonitoring Service Centres (TSCs). It centralizes the reception, storage, and management of wirelessly transmitted ECG data from ambulatory cardiac monitors. This allows technicians to remotely configure devices, review physiological data, and generate reports—supporting continuous remote patient monitoring for cardiovascular care.
How is the EMMa software supplied and what are its sterility and reuse requirements?
The EMMa software is supplied as an installation package for servers, meaning it is not a physical device requiring sterility. Since it operates as a reusable, non-sterile system, it does not need to meet sterile handling protocols. It is intended for repeated use within clinical environments where remote cardiac monitoring is conducted.
Is the EMMa software compatible with multiple types of ambulatory cardiac monitors?
Yes, the EMMa software is designed to integrate with a range of ambulatory cardiac monitors, as indicated by its FDA 510(k) clearance under product code DSI (Detector and Alarm for Arrhythmia). The device supports wireless transmission of ECG data from these monitors, enabling seamless remote monitoring across compatible systems.
What regulatory pathway does the EMMa software follow, and what does this mean for its use?
The EMMa software holds FDA 510(k) clearance (K153477) under the traditional review pathway, classifying it as a Class II medical device with special controls. This means it has undergone rigorous evaluation to ensure safety and effectiveness for its intended use in remote cardiac monitoring, providing confidence in its clinical reliability and compliance with U.S. regulatory standards.
Does the EMMa software require any specific storage conditions?
As server-side software, the EMMa system does not have physical storage requirements like temperature or humidity controls. However, it must be installed on compliant servers with adequate hardware specifications to support continuous data processing, storage, and transmission. Ensure the server environment meets IT security and data protection standards for healthcare applications.