# K240108: Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)

- Pathway: 510(k) (Traditional)
- Applicant: Gymmax Technology Shenzhen Co., Ltd.
- Decided: Jun 10, 2024 after 146 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: 1 generation back to K190617 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210383: Wrap Accessory Electrodes, Hi-Dow International, Inc. (2021) Summary page 5.
- K190617: Wrap accessory electrodes, Hi-Dow International, Inc. (2019) Summary page 6.

## Indications for use
The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, hand, wrist, ankle, knee and foot.

Source page: https://510kreport.com/device/K240108
Methodology: https://510kreport.com/methodology