# K130816: Interx Sterile Self-Adhesive Dual Electrode (Issde)

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Resource Group, Inc.
- Decided: Jun 21, 2013 after 88 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
Longest line of descent: 1 generation back to K900997 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083350: Tens/Nmes/Fes Stimulating Electrode, Covidien LP (2009) Summary page 1.
- K900997: K-Sterile Tens Electrodes, Katecho, Inc. (1990) Summary page 1.
- K900519: Classic Ecg/Stimulating NO. 1700 Series, Classic Medical Products, Inc. (1990) Summary page 1.

## Indications for use
ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator. The ISSDE provides the conductive interface between the InterX stimulation device and the patient’s skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use.

Source page: https://510kreport.com/device/K130816
Methodology: https://510kreport.com/methodology