# K983097: Tens/Fes/Nmes Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Uni-Patch, Inc.
- Decided: Sep 17, 1999 after 389 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 K871222 (1987). 2 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871222: Tantone Multi-Day #633 Tens Electrode, Uni-Patch, Inc. (1987) Summary page 4.
- K901575: Reusable Tens Paravertebral Pad #641 Back Electrod, Pioneering Technologies, Inc. (1990) Summary page 4.

## Most influential descendants
- K070807: Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes (2007), 6 descendants of its own
- K080386: Columbia 600 Electrode, Columbia 06 Leadwire (2008), 4 descendants of its own
- K083756: Guardian 150 Electrode (2009), 3 descendants of its own
- 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

## Indications for use
To conduct electrical stimulation to a patient's skin. Single use. Repositionable, self-adhering. Over-the-counter use.

Source page: https://510kreport.com/device/K983097
Methodology: https://510kreport.com/methodology