# K040207: EP-4 Clinical Stimulator

- Pathway: 510(k) (Special)
- Applicant: Ep Medsystems
- Decided: Feb 27, 2004 after 28 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K092913: EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04 (2009), 0 descendants of its own

## Recalls of this device
- Mar 23, 2009 · Not classified · Z-1422-2009: Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused.
- 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/K040207
Methodology: https://510kreport.com/methodology