510(k) Report

Devices descending from K925806

21 later devices reach RH-801, Model Transq through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983484Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi199820—
+2K070427Dupel Transport Iontophoresis SystemEmpi20070—
+2K052019North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc.20052—
+2K041101Medical Adhesiveonline, LLC. Iontophoresis Drug Delivery Electrodes, Models 23001…Medical Adhesiveonline, LLC20040—
+2K040495Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402…Naimco, Inc.20045—
+2K031115RH-900Iomed, Inc.20036—
+2K031053Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…Selectivemed Components, Inc.200341
+2K030395Empi Action Patch Iontophoresis SystemEmpi20033—
+2K991991Dupel Iontophoresis SystemEmpi19990—
+3K232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.20230—
+3K132832Activapatch ET Iontophoresis PatchActivatek, Inc.20140—
+3K091326ActivapatchActivatek, Inc.20090—
+3K080580Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model…Axelgaard Mfg. Co., Ltd.20080—
+3K061522Trivarion Buffered Iontophoresis Electrode SystemActivatek, Inc.20062—
+3K060814Dynatron Ion Iontophoresis ElectrodeDynatronics Corp.20061—
+3K060579Comfort/IO Iontophoresis ElectrodesPepin Mfg., Inc.20060—
+3K043047Dynatron Ibox Iontophoresis DeviceDynatronics Corp.20051—
+3K033192RH-950Iomed, Inc.20033—
+4K170291IontoDCSoterix Medical, Inc.20170—
+4K063465Champion Iontophoretic Drug Delivery DeviceIomed, Inc.20071—
+5K072946Hybresis Iontophoresis Drug Delivery SystemEmpi20070—