# K060712: Vitelcare C-Turtle Patient Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Visual Telecommunications Network, Inc.
- Decided: Apr 19, 2006 after 34 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000557 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040581: Medvizertm Vitelcare Patient Monitoring System, Vitel Net (2004) Summary page 1.
- K043368: Vitelcare Turtle, Model 400, Visual Telecommunications Network, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K040283: Biopad, Euroresearch Srl (2005). Our reading of the summary gave K040283, FDA’s number for Biopad (Euroresearch Srl). Its FDA name has none of the distinctive words the summary uses for the device it names, “ViTelCare Turtle 800 Patient Monitoring System”. Kept off the family tree. Summary page 1.

## Indications for use
ViTelCare™ C-Turtle Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference connection when desired. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.

Source page: https://510kreport.com/device/K060712
Methodology: https://510kreport.com/methodology