# K915333: Electrode Using Promeon RG-60 Series Gel

- Pathway: 510(k) (Traditional)
- Applicant: Labeltape Meditect, Inc.
- Decided: Jan 14, 1992 after 49 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K121483: Reusable Cutaneous Electrode (2012), 1 descendant of its own
- K172887: XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) (2018), 0 descendants of its own
- K030375: Soft-Touch Tens Electrode (2003), 0 descendants of its own

## Recalls of this device
- Feb 9, 2012 · Class II · Z-0500-2013: Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have bee

Source page: https://510kreport.com/device/K915333
Methodology: https://510kreport.com/methodology