LogoFDA 510(k) Search
K Number
K002227
Device Name
WANDY SILICONE CONDUCTIVE RUBBER PAD
Manufacturer
WANDY RUBBER INDUSTRIAL CO., LTD
Date Cleared
2001-02-02

(193 days)

Product Code
GXY
Regulation Number
882.1320
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).