# K103796: Telemedcare Health Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Telemedcare Pty, Ltd.
- Decided: Aug 3, 2011 after 219 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: 12 generations back to K864318 (1987). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080798: Intel Health Guide, Model: PHS6000, Intel Corp. (2008) Summary page 1.
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B), Philips Medical Systems (2002) Summary page 1.
- K063612: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2006) Summary page 1.
- K090886: RTX 3371, Tunstall Healthcare (2009) Summary page 1.
- K073038: Carematix Wellness System, Model CWS-5000.1-B, Carematix, Inc. (2008) Summary page 1.
- K100508: Carematix Wellness System, Model CWS-5000.1-B, Carematix, Inc. (2010) Summary page 1.

## Most influential descendants
- K122333: Mobilecare Monitor (2012), 0 descendants of its own

## Indications for use
The TMC Health Monitor is intended to facilitate monitoring and transmission to a remote server of certain physiological parameters relevant to the remote management of health status and chronic disease conditions. The TMC Health Monitor is a system that provides: Monitoring and display of vital signs/health parameters. Management and scheduling of clinical measurements and questionnaires. A web connection to patient health information. Reporting to clinicians and allied health workers. The device has been designed to provide the user with information to assist with an appropriate treatment program or further investigation.

Source page: https://510kreport.com/device/K103796
Methodology: https://510kreport.com/methodology