# K993878: JE 2000

- Pathway: 510(k) (Traditional)
- Applicant: Jack'S Electrodes
- Decided: Feb 1, 2000 after 78 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- 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.

## Indications for use
The electromyograph is intended to be used by a licensed practitioner, for the purpose of diagnostic neurological procedures.

Source page: https://510kreport.com/device/K993878
Methodology: https://510kreport.com/methodology