# K082065: Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare Limited
- Decided: Apr 10, 2009 after 262 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: 4 generations back to K945676 (1995). 9 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062675: Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double Side Series, Gemore Technology Co, Ltd. (2007) Summary page 1.

## Most influential descendants
- K133723: Otc Patch (2014), 3 descendants of its own
- K220524: Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) (2022), 0 descendants of its own
- K151479: EV-820 OTC Pain Relief TENS (2015), 0 descendants of its own
- K150681: Gemore Otc Tens (2015), 0 descendants of its own
- K120516: Long Life Padtm (2012), 0 descendants of its own

## Indications for use
The Well Life Self Adhesive Electrode/CM, FA, PU and SP series are intended for use as a disposable,.conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / AP, CM, FA, PU and SP series are designed and intended to be used With marketed Electrical:Stimulators,'i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Mu'scularfStimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation):

Source page: https://510kreport.com/device/K082065
Methodology: https://510kreport.com/methodology