# K030375: Soft-Touch Tens Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Pain Management Technologies
- Decided: May 5, 2003 after 90 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 K915333 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915333: Electrode Using Promeon RG-60 Series Gel, Labeltape Meditect, Inc. (1992) Summary page 1.
- K912643: Electrode, Skylark Device Co., Ltd. (1992) Summary page 1.

## Indications for use
The PMT Soft-TouchTMexternal TENS Electrodes are indicated for use with transcutaneous electrical stimulation devices as a non-sterile, disposable device for single patient use only. The PMT electrodes provide the conductive interface between the TENS generator and the patient’s skin. The PMT TENS electrode Soft-TouchTMare designed for, and to be used with marketed and FDA approved TENS stimulators.

Source page: https://510kreport.com/device/K030375
Methodology: https://510kreport.com/methodology