510(k) Report

Devices descending from K993081

5 later devices reach IO-Drive through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031053Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…Selectivemed Components, Inc.200341
+2K060579Comfort/IO Iontophoresis ElectrodesPepin Mfg., Inc.20060—
+2K052019North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc.20052—
+3K080580Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model…Axelgaard Mfg. Co., Ltd.20080—
+3K060814Dynatron Ion Iontophoresis ElectrodeDynatronics Corp.20061—