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Iontophoresis is indicated for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.

North Coast Buffered Iontophoresis Electrodes consist of an active drug delivery clectrode 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 several sizes and shapes of drug delivery electrodes to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes. North Coast Buffered Iontophoresis Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and labeling.