# K200942: Well-Life Garment Electrodes (GM Series)

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare Limited
- Decided: Jun 1, 2021 after 419 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: 3 generations back to K932299 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053214: Theraknit Garment Electrode, Neurotron Medical (2005) Summary page 5.
- K171721: Electrodes with silver conductive, Shenzhen Konmed Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
The Well Life Garment Electrodes (GM Series) are intended to be used with legally marketed TENS devices. The Well-Life Garment Electrodes (GM Series) will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. They can be used on body parts such as arm and elbow.

Source page: https://510kreport.com/device/K200942
Methodology: https://510kreport.com/methodology