# K242326: Wave Electrode (AE02-60); Wave Electrode (AE02-50)

- Pathway: 510(k) (Traditional)
- Applicant: Bionit Labs Srl
- Decided: Jan 2, 2025 after 149 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 K032833 (2003). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220002: Dexus Prosthetics System (Model: MSL1, MSR1), Zhejiang Qiangnao Technology Co.,Ltd (2022) Summary page 5.
- K223738: Alpha Control Liner System (ACLS), Coapt (2023) Summary page 5.

## Most influential descendants
- K260453: Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (2026), 0 descendants of its own

## Indications for use
The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.

Source page: https://510kreport.com/device/K242326
Methodology: https://510kreport.com/methodology