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510(k) Data Aggregation
K Number
K061522Device Name
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
Manufacturer
ACTIVA TEK INC
Date Cleared
2006-08-01
(60 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
ACTIVA TEK INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trivarion Buffered Iontophoresis Electrode System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.
Device Description
The Trivarion Buffered Iontophoresis Electrode System consists of a disposable, single-use iontophoresis electrode and return electrode. A packaged 70% isopropyl alcohol patch (Becton Dickinson, Franklin Lakes, NJ 07417) is also included. The Trivarion lontophoresis Electrode System does not include the iontophoresis electrical generator or the electrical lead wires. Commercially available, FDA approved microprocessor controlled constant current generators such as the lomed phoresor or EMPI Dupel may be connected to the Trivarion electrodes. The Trivarion Iontophoresis Electrode is buffered by the use of silver-silver chloride for administered doses in the range of 40-80 mAmp*min for both polarities, negative and positive.
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