# K130360: Constant Care Lilah Home Health Monitoring System - Multi-User Version

- Pathway: 510(k) (Traditional)
- Applicant: Constant Care, LLC
- Decided: Jul 15, 2013 after 152 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: 5 generations back to K040799 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120941: Constant Care Lilah Home Health Monitoring System, Constant Care, LLC (2012) Summary page 2.

## Indications for use
The Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAR Home Health Monitoring System is designed to be used in the home of a patient or healthcare setting to provide remote monitoring for maintenance of chronic disease. The Constant Care L]LAH Home Health Monitoring System provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and real-time video conferencing technology. The Constant Care LILAH Home Health Monitoring System connects to commercially available wirless and wired medical devices such as glucose meters, weight scales, blood pressure monitors, medication reminders, electronic thermometers, peak-flow meters anid pulse cximete-s. The Constant Care IIfAH Home Health Monitoring System stores and displays the information on a computer screen and transmits the information to the Caretaker Portal secure host server using connectivity including, but not limited to, FCC approved Wi-El, Cellular Wireless, Internet, or Ethernet. Healthcare professionals and remote caregivers can review the transmitted information utilizing the Caretaker Portal and set thresholds to trigger non-emergency alerts based on specific thresholds being exceeded. The Constant Care LILAH Home Health Monitoring System is not intended for diagnosis or as a substitute for medicall care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contrindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered. A list of devices that are compatible with the Constant Care LILAH Home.Health Monitoring System will be available in the user's manual anid the Constant Care website.

Source page: https://510kreport.com/device/K130360
Methodology: https://510kreport.com/methodology