# K120516: Long Life Padtm

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: May 17, 2012 after 86 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 K945676 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082065: Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP, Well-Life Healthcare Limited (2009) Summary page 1.

## Indications for use
The LONG LIFE PADM is intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. These pads should be used only with the Oniron Electrotherapy Pain Relief Unit, (PM3030) and applied on normal, healthy, dry, clean skin of adults.

Source page: https://510kreport.com/device/K120516
Methodology: https://510kreport.com/methodology