# K083758: Sensory Nerve Electrodes-Two Finger Rings, Stimulator Probe Electrodes-Facial, Mono, BI- & Tripolar Nerve Stimulators

- Pathway: 510(k) (Traditional)
- Applicant: The Electrode Store, Inc.
- Decided: Aug 14, 2009 after 240 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- 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 Electrode StoreTM Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.

Source page: https://510kreport.com/device/K083758
Methodology: https://510kreport.com/methodology