# K041442: EP-4 Clinical Stimutator

- Pathway: 510(k) (Special)
- Applicant: Ep Medsystems
- Decided: Sep 14, 2004 after 105 days
- Product code: JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only))
- Device class: 2
- Regulation: 21 CFR 870.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Apr 4, 2006 · Not classified · Z-0914-06: Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical 

## Indications for use
The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions.

Source page: https://510kreport.com/device/K041442
Methodology: https://510kreport.com/methodology