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Updated: Mar 17, 2026

Real-time Iontophoresis with Tetramethylammonium to Quantify Volume Fraction and Tortuosity of Brain Extracellular Space
Published on: July 24, 2017
Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes. Final order
Abstract:
The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.
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