# K040966: Modification to Carematix Wellness System

- Pathway: 510(k) (Traditional)
- Applicant: Carematix, Inc.
- Decided: Jun 2, 2004 after 49 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: 6 generations back to K864318 (1987). 17 ancestors in all.
86 later devices descend from it; 16 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B), Philips Medical Systems (2002) Summary page 1.
- K993169: Modification of: Physiological Signal Transmitter and Receiver, Model 3810A, Hewlett-Packard Co. (1999) Summary page 1.
- K011779: Avidcare Series 100 Telemanagement System, Avid Care Corp. (2001) Summary page 1.
- K010029: Home Health Monitoring System, Avid Care Corp. (2001) Summary page 1.
- K030419: Viterion 100 Telehealth Monitor, Viterion Telehealthcare, LLC (2003) Summary page 1.
- K031840: Carematix Wellness System, Carematix, Inc. (2003) Summary page 1.

## Most influential descendants
- K050929: The Hermes System (2005), 45 descendants of its own
- K042273: Modification to Health Buddy with Device Connectivity (2004), 45 descendants of its own
- K050567: Health Buddy Appliance (2005), 40 descendants of its own
- K060843: Modification to Health Buddy Appliance (2006), 39 descendants of its own
- K062215: Confidant 2.0 (2006), 35 descendants of its own

## Indications for use
The Carematix Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as: * Non-invasive blood pressure measurement; * Blood glucose level using a Glucometer; * Patient weight using a stand-on electronic scale • Pulse rate measurement; * Blood hemoglobin oxygen saturation (%SPO2) using a digital Pulse Oximeter; • Prothrombin Time (PT) and International Normalized Ratio (LNR) measurement using an in-home coagulation measurement system; • Body temperature measurement using a digital thermometer; • Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

Source page: https://510kreport.com/device/K040966
Methodology: https://510kreport.com/methodology