Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)— 510(k) K260453
Substantially EquivalentBionit Labs Srl
FDA 510(k) clearance K260453 for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60), Substantially Equivalent on 2026-03-12. Applicant: Bionit Labs Srl. Device class: 2.
Summary
Bionit Labs' record lists two Remote Wave Electrodes, AE03-50 and AE03-60. They're filed under GXY, cutaneous electrodes, and the record doesn't describe them beyond that name and code name.
Class II, 21 CFR 882.1320. The Physical Medicine review panel handled it as a Special 510(k), though the record lists Neurology as the classification panel.
Bionit Labs filed from Soleto, Italy. Review took 29 calendar days (February 11 to March 12, 2026).
Clearance details
- Applicant
- Bionit Labs Srl
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Soleto, IT
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