# K030297: Flexible Rubber Electrodes, Models: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130

- Pathway: 510(k) (Traditional)
- Applicant: Enraf-Nonius, B.V.
- Decided: Apr 28, 2003 after 90 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 K880699 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880699: Endomed CV405, Henley Intl. (1988) Summary page 1.

## Indications for use
Electrical Stimulation

Source page: https://510kreport.com/device/K030297
Methodology: https://510kreport.com/methodology