TCX-I Remote Care Management System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113493 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 TCX-I Remote Care Management System is a device that collects physiological data including weight, blood pressure, pulse rate, and blood glucose from patients and transmits this information to healthcare providers at remote facilities. The system also supports videoconferencing, multimedia education, and messaging capabilities.
The device is installed by trained professionals and operated by patients for data collection. It has FDA 510(k) clearance with K number K113493 and is classified as a Class II device under product code DRG. The system is intended for cardiovascular use and is regulated under 870.2910.
Frequently asked questions
What is the TCX-I Remote Care Management System used for?
The TCX-I Remote Care Management System is designed to collect physiological data such as weight, blood pressure, pulse rate, and blood glucose from patients and transmit this information to healthcare providers at remote facilities. It also supports videoconferencing, multimedia education, and messaging capabilities.
How is the TCX-I Remote Care Management System installed and operated?
The device is installed by trained professionals and is operated by patients for data collection. This setup allows patients to conveniently monitor their vital signs while healthcare providers can remotely access the data for monitoring and consultation purposes.
What is the regulatory status of the TCX-I Remote Care Management System?
The TCX-I Remote Care Management System has FDA 510(k) clearance with K number K113493. It is classified as a Class II device under product code DRG and is intended for cardiovascular use, regulated under 870.2910.
What features does the TCX-I Remote Care Management System offer beyond data collection?
In addition to collecting and transmitting physiological data, the system supports videoconferencing capabilities, multimedia educational resources, and messaging functions to facilitate communication between patients and healthcare providers.
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: Bl Healthcare Remote Care Management System, TCX-I REMOTE CARE MANAGEMENT SYSTEM - Innolitics, Tcx-i Remote Care Management System - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113493 | Class II | Active |
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Manufacturer
- Manufacturer
- Bl Healthcare, Inc.
Sources (1)
- FDA 510(k) K113493 24 fields · synced Sep 26, 2026