# K191620: Vitls Platform

- Pathway: 510(k) (Traditional)
- Applicant: Vitls, Inc.
- Decided: Jun 1, 2020 after 349 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962603 (1997). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172329: Patient Status Engine, Isansys Lifecare, Ltd. (2018) Summary page 4.
- K162137: Fever Scout™ Continuous Monitoring thermometer, VivaLNK, Inc. (2017) Summary page 4.

## Most influential descendants
- K213863: Everion+ System (2023), 1 descendant of its own
- K233418: Biofourmis Everion+ (G2) (2024), 0 descendants of its own

## Indications for use
The Vitls Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in healthcare and home settings. This includes heart rate (HR) and body temperature. The data from the Tego VSS Sensor is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care. The device is intended for use as a general patient monitor, to provide physiological information, on patients who are 2 years of age or older.

Source page: https://510kreport.com/device/K191620
Methodology: https://510kreport.com/methodology