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K Number
K970426

Validate with FDA (Live)

Device Name
VALUETRODE
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
1997-05-09

(94 days)

Product Code
GXY
Regulation Number
882.1320
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K050046,K050469,K081279,K091163,K092546,K130987
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).