PG471W, PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W Fiab Disposable Electrodes with Cable for Electro-St
by Fiab SpA
510(k) K091163
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK091163 | Date22 Jul 2009 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
These devices are disposable adhesive electrodes designed for electrostimulation applications. They facilitate the delivery of electrical impulses to the body for therapeutic or diagnostic purposes, adhering to the skin via conductive gel or adhesive surfaces for consistent signal transmission.
Supplied as single-use, sterile or non-sterile (as specified), these electrodes are intended for use in clinical or home settings. Each model varies in cable length and electrode configuration, with sizes denoted by the model number (e.g., PG479/50W for 50mm width). They comply with FDA 510(k) clearance under the Neurology advisory committee and EU MDR regulations, ensuring adherence to safety and performance standards for electrostimulation therapy.
Other devices from Fiab SpA
Questions
AI-generated answers, 18 Sep 2026
Are these electrodes meant for reuse or are they single-use only, and how does that affect their sterility?
These electrodes are explicitly designed for single-use only, which means they should not be reused after one application. Sterility varies by model—some are supplied sterile while others are non-sterile, as indicated in the product specifications. Since they’re disposable, sterility is critical for clinical settings, ensuring patient safety and preventing cross-contamination.
What are the key differences between the PG479/32W, PG479/50W, and PG479/75W models, and which one should I choose for a patient with a larger treatment area?
The numerical suffix in these models (e.g., 32W, 50W, 75W) refers to the electrode width in millimeters, which determines coverage area. For a larger treatment area, the PG479/75W (75mm width) would be the most appropriate, as it provides broader contact with the skin. The cable length remains consistent across these models, so selection should prioritize the size needed for the patient’s anatomy.
How do I properly store these electrodes before use, and does storage affect their performance or shelf life?
These electrodes should be stored in a cool, dry place, away from direct sunlight or extreme temperatures, as per standard practice for adhesive medical devices. Proper storage ensures the adhesive and conductive gel remain effective. While the manufacturer doesn’t specify an exact shelf life in the provided data, adherence to storage guidelines prevents degradation of the adhesive or conductive properties, which could compromise signal transmission during electrostimulation.
What regulatory pathways have these electrodes gone through, and how does that impact their use in clinical or home settings?
These electrodes are cleared under FDA 510(k) via the Neurology Advisory Committee (K091163) and comply with EU MDR regulations, confirming they meet safety and performance standards for electrostimulation. This clearance allows their use in both clinical and home settings, provided they’re applied correctly per manufacturer instructions. The regulatory route ensures they’re suitable for therapeutic or diagnostic electrical stimulation applications.