# K040663: Telenable Ems System

- Pathway: 510(k) (Traditional)
- Applicant: Molex, Inc.
- Decided: Jun 30, 2004 after 110 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: 1 generation back to K002089 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002089: Rosetta-LT/Rosetta-RX, General Devices (2000) Summary page 1.

## Indications for use
The TelEnable EMS System provides a mechanism to transmit 12-lead ECGs from a portable ECG monitor to a central location such as a hospital. This system connects to the ECG via a standard POTS (Plain Old Telephone System) interface and communicates to the ECG via standard Group 3 facsimile (fax) protocol. All information received by the TelEnable EMS System's mobile component (EMS-Enable) is relayed wirelessly to a central receiving station (EMS Hub). Such a station can be co-located in a hospital or at an EMS dispatch center. The ECGs received may either be printed locally or forwarded, via fax, to the destination specified by the ECG operator. No component of the TelEnable EMS System is connected directly to a patient. The TelEnable EMS System is non-invasive. The ECG monitor operator shall observe all the same precautions when connecting the ECG monitor to the EMS-Enable component as when connecting the ECG monitor directly to the PSTN (Public Switch Telephone Network).

Source page: https://510kreport.com/device/K040663
Methodology: https://510kreport.com/methodology