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510(k) Data Aggregation
K Number
K041101Device Name
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
Manufacturer
Date Cleared
2004-07-07
(72 days)
Product Code
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ADHESIVEONLINE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medical Adhesivesonline, LLC. Iontophoresis Drug Delivery Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
Device Description
The Medical Adhesivesonline, LLC. Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The Medical Adhes. Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCl) and polyurethane foam reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.
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