# K103719: Lifecare Conductive Garments

- Pathway: 510(k) (Abbreviated)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Aug 24, 2011 after 246 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: 2 generations back to K932299 (1994). 4 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 25 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 1.

## Most influential descendants
- K123354: Revitive IX (2013), 19 descendants of its own
- K143207: Revitive IX (OTC) (2015), 17 descendants of its own
- K151834: BEMER Classic Set, BEMER Pro-Set (2017), 11 descendants of its own
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (2021), 5 descendants of its own
- K203710: Storz Medical MAGNETOLITH Muscle Stimulator (2021), 4 descendants of its own

## Indications for use
The Lifecare HC-88 Series Conductive Garments are cutaneous electrodes to be used with legally marketed electrical stimulators (such as powered muscle stimulators and transcutaneous electrical nerve stimulators). The knitted garment electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts include hands (gloves), feet (socks), wrists / elbows (wristlets / elbow guards) and knees (kneecaps).

Source page: https://510kreport.com/device/K103719
Methodology: https://510kreport.com/methodology