Identifiers
- 510(k) Number
- K153275 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aingeal Activity System is a physiological patient monitor designed to detect arrhythmias and generate alarms. Classified under the FDA product code MHX, it falls within the category of Class 2 Cardiovascular devices, specifically as a Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms).
This device is intended for use in clinical settings to continuously monitor and transmit physiological data to a remote application for clinician review. Supplied as a reusable device, it adheres to regulatory standards outlined under FDA regulation 870.1025. The system was cleared through the Traditional 510(k) pathway, with a decision date of February 26, 2016, following a review period of 106 days.
Frequently asked questions
What is the Aingeal Activity System used for?
The Aingeal Activity System is a physiological patient monitor specifically designed to detect arrhythmias and generate alarms. It is intended for use in clinical settings to continuously monitor patients’ heart rhythms and transmit the data to a remote application for review by healthcare professionals. This helps in early detection and management of cardiac irregularities.
Is the Aingeal Activity System reusable or single-use?
The Aingeal Activity System is supplied as a reusable device. This means it is intended for repeated use after proper cleaning, disinfection, and maintenance procedures to ensure safety and reliability in clinical environments.
What regulatory pathway was followed for the Aingeal Activity System?
The Aingeal Activity System was cleared through the Traditional 510(k) pathway by the FDA. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness as a Class 2 Cardiovascular device.
What clinical settings is the Aingeal Activity System intended for?
The Aingeal Activity System is designed for use in clinical settings where continuous monitoring of patients’ heart rhythms is required. This includes hospitals, intensive care units, and other healthcare facilities where arrhythmia detection and remote data transmission are beneficial for patient care.
How does the Aingeal Activity System transmit data for clinician review?
The Aingeal Activity System continuously monitors physiological data and transmits it to a remote application. This allows clinicians to review patient heart rhythms remotely, enabling timely intervention and improved patient management without the need for constant physical monitoring.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K153275 FDA 510(k) - Aingeal Activity System | Intelesens, Ltd., Intelesens, Ltd. FDA 510 (k) Products (2016-2016), FDA Browser - Cleared 510 (K) - Aingeal Activity System (K153275), Aingeal Activity System 510 (k) K153275 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153275 | Class II | Active |
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Manufacturer
- Manufacturer
- Intelesens, Ltd.
Sources (1)
- FDA 510(k) K153275 24 fields · synced Oct 1, 2026