FDA 510(k) · Intelesens
K131000: V-PATCH SYSTEM (Intelesens Limited)
Intelesens Limited received FDA 510(k) K131000 for V-PATCH SYSTEM, with a decision date of Jan 8, 2014 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K131000 |
|---|---|
| Pathway | 510(k) |
| Applicant | Intelesens Limited |
| Device name | V-PATCH SYSTEM |
| Product code | DSI: Detector And Alarm, Arrhythmia |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Apr 10, 2013 |
| Decision date | Jan 8, 2014 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Statement K131000 Page 1 of I 510(k) Number: ______(To be assigned) Device Name: Intelesens V-Patch System 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. Prescription Use X or Over-the-counter use (Pant 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Owen P.Faris -5 dae:214.0 1.08 16,07:1 2 -0500' PDF
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DSI is "Detector And Alarm, Arrhythmia", class 2, 21 CFR 870.1025.
Our labels for filtering: claim AFib / irregular rhythm, sensor ECG electrodes. These are heuristics, not FDA fields.