FORA GW 9014 Telehealth GATEWAY/TD-9014 Telehealth Gateway
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100427 FDA 510(k)
- FDA Product Code
- DRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2910 FDA 510(k)
- Regulation Number
- 870.2910 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FORA GW 9014 Telehealth Gateway/TD-9014 Telehealth Gateway is a physiological signal transmitter and receiver device classified under product code DRG. It is designed to facilitate telehealth communication by transmitting data from compatible patient monitors to remote systems. The device operates as a gateway, enabling data transfer in both home and clinical environments under the direction of a licensed healthcare provider.
This device is supplied as a Class II medical device and is cleared for use in cardiovascular monitoring applications. It is intended for single or multi-patient use in accordance with clinical protocols, and its operation depends on physician prescription. The device is regulated under FDA 510(k) clearance with a traditional substantially equivalent determination, and it is subject to standard storage, handling, and regulatory requirements for telehealth gateways.
Frequently asked questions
What is the FORA GW 9014 Telehealth Gateway used for?
The FORA GW 9014 Telehealth Gateway is designed to facilitate telehealth communication by transmitting data from compatible patient monitors to remote systems, enabling physiological signal transfer in both home and clinical environments under the direction of a licensed healthcare provider, specifically for cardiovascular monitoring applications.
How is the FORA GW 9014 Telehealth Gateway supplied and intended for use?
The device is supplied as a Class II medical device and is intended for single or multi-patient use in accordance with clinical protocols, with operation dependent on physician prescription, and it functions as a physiological signal transmitter and receiver under product code DRG.
What regulatory pathway was used for the FORA GW 9014 Telehealth Gateway?
The FORA GW 9014 Telehealth Gateway received FDA 510(k) clearance with a traditional substantially equivalent determination, as indicated by its K-number K100427 and decision code SESE, and is regulated under standard requirements for telehealth gateways in cardiovascular applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fora Gw 9014 Telehealth Gateway/Td-9014 Telehealth Gateway, Fora Gw 9014 Telehealth Gateway/Td-9014 Telehealth Gateway, FORA GW9014 USER MANUAL Pdf Download | ManualsLib, FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100427 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K100427 24 fields · synced Oct 6, 2026