# K153275: Aingeal Activity System

- Pathway: 510(k) (Traditional)
- Applicant: Intelesens, Ltd.
- Decided: Feb 26, 2016 after 106 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110015: Vitalsens, Aingeal, V-Pod, Intelesens Limited (2011) Summary page 4.

## Indications for use
The Intelesens Aingeal Activity is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. This re-usable device is intended to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting. The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful. The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device also detects and records respiration, skin temperature and activity. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach).

Source page: https://510kreport.com/device/K153275
Methodology: https://510kreport.com/methodology