# K100508: Carematix Wellness System, Model CWS-5000.1-B

- Pathway: 510(k) (Special)
- Applicant: Carematix, Inc.
- Decided: May 5, 2010 after 72 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: 8 generations back to K864318 (1987). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 1.
- K073038: Carematix Wellness System, Model CWS-5000.1-B, Carematix, Inc. (2008) Summary page 1.

## Most influential descendants
- K103796: Telemedcare Health Monitor (2011), 1 descendant of its own
- K122333: Mobilecare Monitor (2012), 0 descendants of its own

## Indications for use
The CarematiXTM Wellness System is a physiological monitdring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the heaaithcare 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; Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SPO 2) using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement system; Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale 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/K100508
Methodology: https://510kreport.com/methodology