Cleared Traditional

Wave Electrode (AE02-60); Wave Electrode (AE02-50)

K242326 · Bionit Labs Srl · Neurology

Jan 2025

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K242326 is an FDA 510(k) clearance for the Wave Electrode (AE02-60); Wave Electrode (AE02-50), a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bionit Labs Srl (Soleto, IT). The FDA issued a Cleared decision on January 2, 2025, 149 days after receiving the submission on August 6, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K242326 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2024
Decision Date	January 02, 2025
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF