# K132422: Pals Platinum Neurostimulation Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Axelgaard Mfg. Co., Ltd.
- Decided: Feb 13, 2014 after 192 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: 6 generations back to K945676 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874469: Transcutaneous Electric Nerve Stimulation (Tens), Axelgaard Mfg. Co., Ltd. (1988) Summary page 1.
- K083302: Lifecare Electrodes, Everyway Medical Instruments Co.,Ltd (2009) Summary page 1.
- K130987: Valutrode Neurostimlation Electrodes, Axelgaard Mfg. Co., Ltd. (2013) Summary page 1.

## Indications for use
PALS® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

Source page: https://510kreport.com/device/K132422
Methodology: https://510kreport.com/methodology