# K131720: Hivox Self Adhesive Electrode Gel Pads

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: Jul 25, 2014 after 408 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: 2 generations back to K070612 (2007). 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)
- K070612: Top-Rank Adhesive Electrode, Top-Rank Health Care Equipment Co., Ltd. (2007) Summary page 1.
- K132588: Adhesive Electrodes, Top-Rank Health Care Equipment Co., Ltd. (2013). Cleared while this submission was under review Summary page 1.
- K000947: Ultrastim Electrode, Model US4040, Axelgaard Mfg. Co., Ltd. (2000) Summary page 1.

## Indications for use
HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode and not an electrode itself

Source page: https://510kreport.com/device/K131720
Methodology: https://510kreport.com/methodology