# K070807: Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes

- Pathway: 510(k) (Abbreviated)
- Applicant: Pepin Mfg., Inc.
- Decided: May 23, 2007 after 58 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: 2 generations back to K871222 (1987). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932849: Pmi Tens Electrode, Pepin Mfg., Inc. (1994) Summary page 1.
- K010431: Lead-Lok Reusable Tens/ Nmes Electrodes, Lead-Lok, Inc. (2001) Summary page 1.
- K983097: Tens/Fes/Nmes Electrodes, Uni-Patch, Inc. (1999) Summary page 1.
- K023347: Vital Stim, Chattanooga Group (2002) Summary page 1.

## Most influential descendants
- 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
- K113375: Eswallow Usa Electrode,Eswallow Usa Leadwire (2013), 0 descendants of its own

## Indications for use
The Pepin Manufacturing, Inc. cutaneous electrotherapy and recording electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals. Example electrical stimulation current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. b) Electrical muscle stimulation (EMS); Powered Muscle Stimulators. c) Functional electrical stimulation (FES). d) Galvanic stimulation. e) Microcurrent electrical nerve stimulation (MENS). f) Interferential stimulation. g) Neuromuscular electrical stimulation (NMES).

Source page: https://510kreport.com/device/K070807
Methodology: https://510kreport.com/methodology