Device, Iontophoresis, Other Uses
FDA product code EGJ · Class II (moderate risk) · 21 CFR 890.5525 · Physical Medicine
73510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Empi 11
- Iomed, Inc. 11
- Life-Tech Intl., Inc. 4
- Activatek, Inc. 3
- Selectivemed Components, Inc. 3
- Acclarent, Inc. 3
- Mattioli Engineering Corp. 2
- General Medical Co. 2
- Dynatronics Corp. 2
- R. A. Fischer Co. Corp. 2
- L.S. Scientific 1
- Wr Medical Electronics Co. 1
- Skylark Device Co., Ltd. 1
- Maxxim Medical 1
- Parker Laboratories, Inc. 1
- Henley Intl. 1
- Xomed, Inc. 1
- Taiwan Medical Electronics Co., Ltd. 1
- Kal Life Systems 1
- Santa Barbara Medco, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01)EGJ · Traditional | Taiwan Medical Electronics Co., Ltd. | 04/01/2025SE |
| K241267 | Hidroxa SE30EGJ · Traditional | Hidroxa Medical AB | 10/17/2024SE |
| K232020 | Iontophoresis ElectrodesEGJ · Traditional | Top-Rank Health Care Co., Ltd. | 10/16/2023SE |
| K192749 | DermadryEGJ · Traditional | Dermadry Laboratories, Inc. | 02/10/2020SE |
| K191436 | SaalioEGJ · Traditional | Saalmann Medical GmbH & Co. KG | 10/18/2019SE |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEEGJ · Traditional | Hightech Development | 06/15/2018SE |
| K170291 | IontoDCEGJ · Traditional | Soterix Medical, Inc. | 05/01/2017SE |
| K150453 | TULA Iontophoresis System with EarsetEGJ · Special | Acclarent, Inc. | 05/20/2015SE |
| K133033 | Hidrex PSP1000EGJ · Traditional | Hidrex GmbH | 04/08/2015SE |
| K132832 | Activapatch Et Iontophoresis PatchEGJ · Traditional | Activatek, Inc. | 02/13/2014SE |
| K110636 | Tula Iontophoresis SystemEGJ · Traditional | Acclarent, Inc. | 06/16/2011SE |
| K083016 | ActhydermEGJ · Traditional | Microlab Americas, Inc. | 06/16/2009SE |
| K091326 | ActivapatchEGJ · Traditional | Activatek, Inc. | 05/27/2009SE |
| K080580 | Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model…EGJ · Traditional | Axelgaard Mfg. Co., Ltd. | 06/18/2008SE |
| K073276 | Iontophoresis SystemEGJ · Traditional | Acclarent, Inc. | 03/05/2008SE |
| K072946 | Hybresis Iontophoresis Drug Delivery SystemEGJ · Special | Empi | 11/16/2007SE |
| K070427 | Dupel Transport Iontophoresis SystemEGJ · Traditional | Empi | 05/14/2007SE |
| K061849 | MesodermEGJ · Traditional | Aa Advanced Technology, Inc. | 04/30/2007SE |
| K062792 | Erchonia IOTO_240EGJ · Traditional | Erchonia Medical, Inc. | 03/01/2007SE |
| K063465 | Champion Iontophoretic Drug Delivery DeviceEGJ · Traditional | Iomed, Inc. | 02/28/2007SE |
| K061522 | Trivarion Buffered Iontophoresis Electrode SystemEGJ · Traditional | Activatek, Inc. | 08/01/2006SE |
| K060814 | Dynatron Ion Iontophoresis ElectrodeEGJ · Traditional | Dynatronics Corp. | 06/14/2006SE |
| K060579 | Comfort/Io Iontophoresis ElectrodesEGJ · Abbreviated | Pepin Mfg., Inc. | 04/20/2006SE |
| K060236 | MW-1000 Iontophoretic Drug Delivery ElectrodeEGJ · Traditional | Iomed, Inc. | 03/31/2006SE |
| K052019 | North Coast Buffered Iontophoresis ElectrodeEGJ · Traditional | North Coast Medical, Inc. | 11/04/2005SE |
| K043047 | Dynatron Ibox Iontophoresis DeviceEGJ · Traditional | Dynatronics Corp. | 01/07/2005SESU |
| K042590 | Transderm Ionto System, MK 2EGJ · Traditional | Mattioli Engineering Corp. | 10/14/2004SE |
| K041101 | Medical Adhesiveonline, LLC Iontophoresis Drug Delivery Electrodes, Models 23001, 23002…EGJ · Traditional | Medical Adhesiveonline, LLC | 07/07/2004SE |
| K040495 | Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402…EGJ · Traditional | Naimco, Inc. | 04/22/2004SE |
| K032968 | Trsansderm Ionto SystemEGJ · Traditional | Mattioli Engineering Corp. | 12/02/2003SE |
| K031769 | E-StripEGJ · Traditional | Eemso, Inc. | 10/14/2003SN |
| K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…EGJ · Traditional | Selectivemed Components, Inc. | 05/20/2003SE |
| K022950 | Miniphysionizer 2.0 and ElectrodesEGJ · Traditional | Physion, Inc. | 04/18/2003SE |
| K030395 | Empi Action Patch Iontophoresis SystemEGJ · Traditional | Empi | 04/08/2003SE |
| K020476 | Medion 6000EGJ · Traditional | Selectivemed Components, Inc. | 05/03/2002SE |
| K000574 | Iontophoretic Drug Delivery Electrode, Iontophoretic Electrode (Active)EGJ · Traditional | Wr Medical Electronics Co. | 08/09/2000SE |
| K993081 | Io-DriveEGJ · Traditional | Selectivemed Components, Inc. | 03/03/2000SE |
| K992708 | IontopatchEGJ · Traditional | Birch Point Medical, Inc. | 02/01/2000SE |
| K991991 | Dupel Iontophoresis SystemEGJ · Traditional | Empi | 09/10/1999SE |
| K982668 | Phoresor Ii,Model PM900EGJ · Traditional | Iomed, Inc. | 03/02/1999SE |
| K983484 | Dupel B.L.U.E. Small Iontophoresis ElectrodeEGJ · Traditional | Empi | 12/28/1998SE |
| K970491 | Dupel II Buffered Iontophoresis ElectrodesEGJ · Traditional | Empi | 05/30/1997SE |
| K964208 | MD-1A Galvanic UnitEGJ · Traditional | R. A. Fischer Co. Corp. | 04/30/1997SE |
| K946337 | IT-727 (Also Known AS IT-610, IT-600 and Dynaphor IIEGJ · Traditional | Skylark Device Co., Ltd. | 12/20/1995SE |
| K935868 | Dynaphor(Tm) TwoEGJ · Traditional | Maxxim Medical | 03/15/1995SE |
| K934335 | Phoresor II Auto, Model PM800 ModificationEGJ · Traditional | Iomed, Inc. | 07/26/1994SE |
| K932621 | RH-801/GS Model TRANSQ(R)1EGJ · Traditional | Iomed, Inc. | 07/26/1994SE |
| K932620 | RH-806/GS Model TRANSQ(R)2EGJ · Traditional | Iomed, Inc. | 07/26/1994SE |
| K915444 | Dupel Iontophoresis DeviceEGJ · Traditional | Empi | 07/15/1994SE |
| K913601 | MicrophorEGJ · Traditional | Life-Tech Intl., Inc. | 07/15/1994SE |
| K925806 | RH-801, Model TransqEGJ · Traditional | Iomed, Inc. | 07/14/1994SE |
| K925800 | RH-806, Model TransqEGJ · Traditional | Iomed, Inc. | 07/14/1994SE |
| K914621 | Iontophoresis Device, ModificationEGJ · Traditional | Iomed, Inc. | 12/20/1991SEKD |
| K914264 | Transq 2EGJ · Traditional | Iomed, Inc. | 12/20/1991SEKD |
| K912015 | TBD, Empi Buffered Iontophoresis Electroded Mdl. 3EGJ · Traditional | Empi | 11/15/1991SE |
| K912014 | TBD, Empi Buffered Iontophoresis Electrodes Mdl. 2EGJ · Traditional | Empi | 10/28/1991SE |
| K903093 | Iontophoresis DeviceEGJ · Traditional | Empi | 10/11/1990SESD |
| K895365 | MD-2 Iontophoresis UnitEGJ · Traditional | R. A. Fischer Co. Corp. | 06/26/1990SESD |
| K896444 | Iontophoresis Device - Electrode RH 800EGJ · Traditional | Iomed, Inc. | 05/10/1990SESD |
| K900363 | Neophor-McEGJ · Traditional | L.S. Scientific | 04/25/1990SESD |
| K896703 | TBD Iontophoresis ElectrodeEGJ · Traditional | Empi | 02/26/1990SESD |
| K894549 | Dynaphor(Tm) 101, Iontophoresis DeviceEGJ · Traditional | Henley Intl. | 02/09/1990SESD |
| K884834 | Xomed Ionesthetizer(Tm)EGJ · Traditional | Xomed, Inc. | 02/15/1989SESD |
| K882554 | Meditrode KitEGJ · Traditional | Life-Tech Intl., Inc. | 12/23/1988SESD |
| K871869 | Modified Use for Model 6110A Iontophoretic Appli.EGJ · Traditional | Life-Tech Intl., Inc. | 08/11/1987SESD |
| K872040 | Phoresor II (TM), Model PM700EGJ · Traditional | Motion Control, Inc. | 08/04/1987SE |
| K863166 | Model 6110 Iontophoretic ApplicatorEGJ · Traditional | Life-Tech Intl., Inc. | 03/04/1987SE |
| K853635 | Subderm TMEGJ · Traditional | General Medical Co. | 12/20/1985SE |
| K850508 | Logikal Lontophoresis Unit -Anesthesia InotophoresEGJ · Traditional | Kal Life Systems | 05/15/1985SE |
| K842483 | Santa Barbara Medco-Lantophoretic ApplicEGJ · Traditional | Santa Barbara Medco, Inc. | 08/31/1984SE |
| K831320 | DrionicEGJ · Traditional | General Medical Co. | 07/19/1983SE |
| K770717 | Iontophoresis System Module, DM 500EGJ · Traditional | Sorensen Research | 08/15/1977SE |
| K771130 | DesensitronEGJ · Traditional | Parker Laboratories, Inc. | 07/15/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2197-2025 Class II | IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch…The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used… | LTS Therapy Systems, LLC | 05/22/2025Open, Classified |
| Z-2196-2025 Class II | IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is…The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used… | LTS Therapy Systems, LLC | 05/22/2025Open, Classified |
| Z-0454-2022 Class III | iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System…The dosage information on the pouch is incorrect; the primary carton label is correct. | Tapemark Company | 11/10/2021Terminated |
| Z-1238-2017 Class III | Daavlin Aquex (DAAV1000)The device was reclassified from a class III device to a class II device and there are new documentation… | Hidrex GmbH | 01/30/2017Terminated |
| Z-1237-2017 Class III | Hidrex USA DVP1000The device was reclassified from a class III device to a class II device and there are new documentation… | Hidrex GmbH | 01/30/2017Terminated |
| Z-1236-2017 Class III | Hidrex USA DP450The device was reclassified from a class III device to a class II device and there are new documentation… | Hidrex GmbH | 01/30/2017Terminated |