# K083046: Fora Telehealth System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jan 16, 2009 after 94 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031840: Carematix Wellness System, Carematix, Inc. (2003) Summary page 1.
- K051470: Remote Care Management Systems (RCMS), Bl Healthcare, Inc. (2005) Summary page 1.

## Indications for use
The FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The system serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of'the historical test results, home users and healthcare professionals can do health management effectively The FORA TeleHealth System may not be used as a substitute for direct medical intervention or emergency care Interpretation of the information collected and transmitted requires clinical judgment by an appropnate healthcare professional This system is to be used or prescnbed on the order of a physician

Source page: https://510kreport.com/device/K083046
Methodology: https://510kreport.com/methodology