# K013533: Ems Telemedicine Option (for Gems Series 4000)

- Pathway: 510(k) (Traditional)
- Applicant: General Devices
- Decided: Jan 18, 2002 after 87 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 K896153 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896153: Modified DR-2C/PMC 100, General Devices (1990) Summary page 1.
- K002089: Rosetta-LT/Rosetta-RX, General Devices (2000) Summary page 1.

## Indications for use
The ECG Telemedicine Option for the GEMS Series 4000 Communications Console is indicated for use when it is desired to communicate with distant medical devices in an EMS pre-hospital setting and to acquire and present information, such as single/12-lead ECG and physiologic/non-physiologic data, or other physiologic information which has been gathered by these devices.

Source page: https://510kreport.com/device/K013533
Methodology: https://510kreport.com/methodology