Cleared Special

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

K260453 · Bionit Labs Srl · Physical Medicine

Mar 2026

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K260453 is an FDA 510(k) clearance for the Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60), a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bionit Labs Srl (Soleto, IT). The FDA issued a Cleared decision on March 12, 2026, 29 days after receiving the submission on February 11, 2026. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K260453 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2026
Decision Date	March 12, 2026
Days to Decision	29 days
Submission Type	Special
Review Panel	Physical Medicine (PM)
Summary	Summary PDF