# K100427: Fora GW 9014 Telehealth Gateway/TD-9014 Telehealth Gateway

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: May 28, 2010 after 101 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). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041816: RTX3320PSTN Wireless Telehealth Gateway, Rtx Healthcare A/S (2004) Summary page 1.

## Most influential descendants
- K103643: Ascot Home Medical Monitoring System (HMMS) (2011), 0 descendants of its own

## Indications for use
The FORA GW 9014/TD-9014 TeleHealth Gateway is for use by patients at home or at clinical settings. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. It serves as the remote communication link between various FDA-cleared compatible monitors and the compatible healthcare facility at another location. The healthcare facility could be with the healthcare provider, or at a disease management center, or other out-of-hospital caregivers. This device is intended to transmit selected medical information (i.e. blood glucose, blood pressure, body weight, body temperature, body fat, and body hydration) measured by FDA approved medical devices via RS232 or wireless connections over the internet or residential telephone line. This device does not measure, interpret or make any decisions on the data that it conveys. This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time critical data. This device is not for use in systems which substitute for medical care, or for patients requiring direct medical supervision. This device is not intended for patients requiring direct medical supervision or emergency intervention. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted.

Source page: https://510kreport.com/device/K100427
Methodology: https://510kreport.com/methodology