# K131000: V-Patch System

- Pathway: 510(k) (Traditional)
- Applicant: Intelesens Limited
- Decided: Jan 8, 2014 after 273 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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 K882803 (1988). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100155: Truvue Wireless Ambulatory Ecg Monitoring System, Biomedical Systems Corp. (2010) Summary page 1.

## Indications for use
The Intelesens V-Patch System is designed to monitor and transmit ECG data to a web based host application for display or analysis by aclinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare or home environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in ani unmonitored or unobserved situation. The re-usable device is intended to be used with a single use electrode on the patient for up to seven days. The V-Patch-System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of' an arrhythmia event. The V-Patch also has a patient activated button that allows ECG to be recorded and transmitted on-demand should the patient experience any relevant symptoms.

Source page: https://510kreport.com/device/K131000
Methodology: https://510kreport.com/methodology