# K121483: Reusable Cutaneous Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ampcare, LLC
- Decided: Oct 15, 2012 after 150 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: 5 generations back to K871222 (1987). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 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.
- K080386: Columbia 600 Electrode, Columbia 06 Leadwire, Columbia Scientific Development, LLC (2008) Summary page 1.
- K852267: Electrical Nerve Stimulation (Tens) Electrodes, Axelgaard Mfg. Co., Ltd. (1985) Summary page 1.
- K083756: Guardian 150 Electrode, Selectivemed Components, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulation current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief b) Electrical muscle stimulation (EMS) for neck muscle stimulation. c) Functional electrical stimulation (FES) d) Galvanic stimulation. e) Microcurrent electrical nerve stimulation (MENS). f) Interferential (IF) stimulation. g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for phatyngeal contraction.

Source page: https://510kreport.com/device/K121483
Methodology: https://510kreport.com/methodology