# K043368: Vitelcare Turtle, Model 400

- Pathway: 510(k) (Special)
- Applicant: Visual Telecommunications Network, Inc.
- Decided: Feb 1, 2005 after 55 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: 2 generations back to K000557 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K060712: Vitelcare C-Turtle Patient Monitoring System (2006), 0 descendants of its own

## Indications for use
ViTelCareTM Turtle 400 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 MedVizerTM ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. 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/K043368
Methodology: https://510kreport.com/methodology