510(k) Report

Devices descending from K912014

6 later devices reach TBD, Empi Buffered Iontophoresis Electrodes MDL. 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993081IO-DriveSelectivemed Components, Inc.20005—
+2K031053Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…Selectivemed Components, Inc.200341
+3K060579Comfort/IO Iontophoresis ElectrodesPepin Mfg., Inc.20060—
+3K052019North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc.20052—
+4K080580Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model…Axelgaard Mfg. Co., Ltd.20080—
+4K060814Dynatron Ion Iontophoresis ElectrodeDynatronics Corp.20061—