# K091163: PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W Fiab Disposable Electrodes with Cable for Electro-ST

- Pathway: 510(k) (Traditional)
- Applicant: Fiab Spa
- Decided: Jul 22, 2009 after 91 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 K970426 (1997). 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)
- K970426: Valuetrode, Axelgaard Mfg. Co., Ltd. (1997) Summary page 1.

## Indications for use
PG47xW SERIES cutaneous disposable electrodes with cable connection are intended for use with neurostimulation equipment designed for transmission of electric impulses to patient's skin.

Source page: https://510kreport.com/device/K091163
Methodology: https://510kreport.com/methodology