Product code EGJ
- Device name
- Device, Iontophoresis, Other Uses
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5525
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | 2025-04-01 |
| K241267 | Hidroxa SE30 | Hidroxa Medical AB | 2024-10-17 |
| K232020 | Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. | 2023-10-16 |
| K192749 | Dermadry | Dermadry Laboratories, Inc. | 2020-02-10 |
| K191436 | Saalio | Saalmann Medical GmbH & Co. KG | 2019-10-18 |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE | Hightech Development | 2018-06-15 |
| K170291 | IontoDC | Soterix Medical, Inc. | 2017-05-01 |
| K150453 | TULA Iontophoresis System with Earset | Acclarent, Inc. | 2015-05-20 |
| K133033 | HIDREX PSP1000 | Hidrex GmbH | 2015-04-08 |
| K132832 | ACTIVAPATCH ET IONTOPHORESIS PATCH | Activatek, Inc. | 2014-02-13 |
| K110636 | TULA IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2011-06-16 |
| K083016 | ACTHYDERM | Microlab Americas, Inc. | 2009-06-16 |
| K091326 | ACTIVAPATCH | Activatek, Inc. | 2009-05-27 |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | Axelgaard Mfg. Co., Ltd. | 2008-06-18 |
| K073276 | IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2008-03-05 |
| K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | Empi | 2007-11-16 |
| K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | Empi | 2007-05-14 |
| K061849 | MESODERM | Aa Advanced Technology, Inc. | 2007-04-30 |
| K062792 | ERCHONIA IOTO_240 | Erchonia Medical, Inc. | 2007-03-01 |
| K063465 | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE | Iomed, Inc. | 2007-02-28 |
| K061522 | TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM | Activatek, Inc. | 2006-08-01 |
| K060814 | DYNATRON ION IONTOPHORESIS ELECTRODE | Dynatronics Corp. | 2006-06-14 |
| K060579 | COMFORT/IO IONTOPHORESIS ELECTRODES | Pepin Mfg., Inc. | 2006-04-20 |
| K060236 | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE | Iomed, Inc. | 2006-03-31 |
| K052019 | NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE | North Coast Medical, Inc. | 2005-11-04 |
| K043047 | DYNATRON IBOX IONTOPHORESIS DEVICE | Dynatronics Corp. | 2005-01-07 |
| K042590 | TRANSDERM IONTO SYSTEM, MK 2 | Mattioli Engineering Corp. | 2004-10-14 |
| K041101 | MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 | Medical Adhesiveonline, LLC | 2004-07-07 |
| K040495 | NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 | Naimco, Inc. | 2004-04-22 |
| K032968 | TRSANSDERM IONTO SYSTEM | Mattioli Engineering Corp. | 2003-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10768627016497 | Push Patch Controlled Released 12.0 | NORTH COAST MEDICAL, INC. | 2025-12-01 |
| 00768627016995 | PushPatch Delicate (6) | NORTH COAST MEDICAL, INC. | 2025-12-01 |
| 10768627016299 | ActivaTek Ionto4 Kit | NORTH COAST MEDICAL, INC. | 2025-04-02 |
| 10768627016305 | ActivaTek Ionto4 Kit | NORTH COAST MEDICAL, INC. | 2025-04-02 |
| 10768627016312 | ActivaTek Ionto4 Butterfly | NORTH COAST MEDICAL, INC. | 2025-04-02 |
| 00850030915078 | Dupel BLUE | Clearlake-Tech Inc. | 2023-08-02 |
| 00850030915047 | Dupel BLUE | Clearlake-Tech Inc. | 2023-08-02 |
| 00092237901779 | Ionto Plus Large Electrode | Drive Devilbiss Healthcare | 2018-09-26 |
| 00092237901762 | Ionto Plus Medium Electrodes | Drive Devilbiss Healthcare | 2018-09-26 |
| 00092237901755 | Ionto Plus Small Electrode | Drive Devilbiss Healthcare | 2018-09-26 |
| 00092237901748 | Ionto Plus Butterfly | Drive Devilbiss Healthcare | 2018-09-26 |
| 00017344000092 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000122 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000115 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000108 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 10017344000068 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000085 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000078 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000061 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000054 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000047 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000030 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000023 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000016 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00017344000009 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 10017344000075 | Drionic TM | GENERAL MEDICAL COMPANY | 2016-09-22 |
| 00768627892506 | Norco | ACTIVATEK INC. | 2014-09-23 |
| 00768627892513 | Norco | ACTIVATEK INC. | 2014-09-23 |
| 00768627892520 | Norco | ACTIVATEK INC. | 2014-09-23 |
| 00768627892551 | Norco | ACTIVATEK INC. | 2014-09-23 |