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510(k) Data Aggregation
K Number
K083016Device Name
ACTHYDERM
Manufacturer
Date Cleared
2009-06-16
(250 days)
Product Code
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
MICROLAB AMERICAS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ActhyDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
Device Description
ActhyDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. The microprocessor bas four pre-set programs for penetration of the 1) epidermis, 2) dermis, 3) adipose, 4) muscle. It has a dispersive electrode and roller electrodes. An FDA approved conductive grounding pad is also required prior to its use. Introducing ions can be accomplished with ActhyDerm's Dispensing Electrode and roller using methods described with operator's manual: roller conducts current to the skin via the product to be delivered. The product has a positive charge, the current coming into the roller has a positive charge and when they meet the current are diffused into the skin are diffused into the skin.
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