Class Class II
Wave Electrode (AE02-60); Wave Electrode (AE02-50) (K242326)
Description
Wave Electrode (AE02-60); Wave Electrode (AE02-50) by Bionit Labs Srl, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242326
Clearance Date2025-01-02
Clearance TypeTraditional
Product CodeGXY
Regulation Number882.1320
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242326
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Wave Electrode (AE02-60); Wave Electrode (AE02-50) (K242326) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023 |
| K220002 | Dexus Prosthetics System (Model: MSL1, MSR1) | Zhejiang Qiangnao Technology Co.,Ltd | 2022 |
Trace the full predicate network for K242326
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.