Reusable Stimulating Electrodes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111270 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Reusable Stimulating Electrodes are classified as Electrode, Cutaneous, designed to apply electrical stimulation currents to the patient’s skin or to record physiological signals. These devices facilitate neuromodulation, diagnostic monitoring, or therapeutic interventions in neurology applications by delivering controlled electrical impulses or capturing bioelectric signals for analysis.
These electrodes are intended for reusable clinical use and are regulated under FDA 510(k) clearance (K111270) as a Class II device under regulation 882.1320. They are supplied sterile or non-sterile based on clinical requirements, with proper cleaning and reprocessing protocols mandated for reuse. Compliance with FDA guidelines ensures safe, repeated application in neurological assessments or treatments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: REUSABLE STIMULATING ELECTRODES (K111270) — FDA 510 (k) | Innolitics, Bio-Protech | Medical Electrode & Surgical Device Manufacturer, REUSABLE STIMULATING ELECTRODES 510 (k) K111270 - FDA.report, Amazon.com: Bio Protech Electrodes, Reusable Stimulating Electrodes - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111270 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- FDA Applicant
- Bio Protech, Inc.
Sources (1)
- FDA 510(k) K111270 24 fields · synced Sep 19, 2026