# K042301: Protens Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Sep 3, 2004 after 9 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 Bio Protech, Inc. PROTENS are designed and intended to be used with marketed transcutaneous electrical nerve stimulators (TENS). The PROTENS electrodes provide the conductive interface between the TENS generator and the patient's skin.

Source page: https://510kreport.com/device/K042301
Methodology: https://510kreport.com/methodology