# K080902: Frems SSC Disposable Foam Electrodes, Model 800-000-057; Frems SSC Disposable Non-Woven Electrodes, Model 800-000-058

- Pathway: 510(k) (Abbreviated)
- Applicant: Lorenz Biotech S.P.A.
- Decided: Jun 13, 2008 after 72 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 K822224 (1982). 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)
- K831785: Neuro Ease, Andover Medical, Inc. (1983) Summary page 1.
- K822224: Empi Single Use, Empi (1982) Summary page 1.
- K854513: Empi, NMS/Sue Cutaneous Electrode, Empi (1985) Summary page 1.

## Indications for use
The Lorenz Biotech S.p.A. FREMS SSC Disposable (Foam and Non-Woven) Electrodes are accessories to the Lorenz Biotech Aptiva and are intended to be used for electrical stimulation. They are non-sterile and for single patient use only.

Source page: https://510kreport.com/device/K080902
Methodology: https://510kreport.com/methodology