# K260453: Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

- Pathway: 510(k) (Special)
- Applicant: Bionit Labs Srl
- Decided: Mar 12, 2026 after 29 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: 6 generations back to K032833 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242326: Wave Electrode (AE02-60); Wave Electrode (AE02-50), Bionit Labs Srl (2025) Summary page 5.

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

Source page: https://510kreport.com/device/K260453
Methodology: https://510kreport.com/methodology