# K232995: Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Roundwhale Technology Co., Ltd.
- Decided: Jan 11, 2024 after 111 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 K932299 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203158: BioWave BioWraps, Biowave Corporation (2021) Summary page 8.
- K171798: Silverwear Silver Pro Garment Device, Media Plus, LLC (2018) Summary page 8.
- K171721: Electrodes with silver conductive, Shenzhen Konmed Technology Co., Ltd. (2018) Summary page 8.

## Indications for use
The Neurological Theray Devices - Accessories including Garment electrodes which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.

Source page: https://510kreport.com/device/K232995
Methodology: https://510kreport.com/methodology