FDA Product Code
FDA Product Code EGJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5525
510(k) Clearances — 73 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | 2025-04-01 | Traditional | PDF ↗ |
| K241267 | Hidroxa SE30 | Hidroxa Medical AB | 2024-10-17 | Traditional | PDF ↗ |
| K232020 | Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. | 2023-10-16 | Traditional | PDF ↗ |
| K192749 | Dermadry | Dermadry Laboratories, Inc. | 2020-02-10 | Traditional | PDF ↗ |
| K191436 | Saalio | Saalmann Medical GmbH & Co. KG | 2019-10-18 | Traditional | PDF ↗ |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE | Hightech Development | 2018-06-15 | Traditional | PDF ↗ |
| K170291 | IontoDC | Soterix Medical, Inc. | 2017-05-01 | Traditional | PDF ↗ |
| K150453 | TULA Iontophoresis System with Earset | Acclarent, Inc. | 2015-05-20 | Special | PDF ↗ |
| K133033 | HIDREX PSP1000 | Hidrex GmbH | 2015-04-08 | Traditional | PDF ↗ |
| K132832 | ACTIVAPATCH ET IONTOPHORESIS PATCH | Activatek, Inc. | 2014-02-13 | Traditional | PDF ↗ |
| K110636 | TULA IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2011-06-16 | Traditional | PDF ↗ |
| K083016 | ACTHYDERM | Microlab Americas, Inc. | 2009-06-16 | Traditional | PDF ↗ |
| K091326 | ACTIVAPATCH | Activatek, Inc. | 2009-05-27 | Traditional | PDF ↗ |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | Axelgaard Mfg. Co., Ltd. | 2008-06-18 | Traditional | PDF ↗ |
| K073276 | IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2008-03-05 | Traditional | PDF ↗ |
| K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | Empi | 2007-11-16 | Special | PDF ↗ |
| K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | Empi | 2007-05-14 | Traditional | PDF ↗ |
| K061849 | MESODERM | Aa Advanced Technology, Inc. | 2007-04-30 | Traditional | PDF ↗ |
| K062792 | ERCHONIA IOTO_240 | Erchonia Medical, Inc. | 2007-03-01 | Traditional | PDF ↗ |
| K063465 | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE | Iomed, Inc. | 2007-02-28 | Traditional | PDF ↗ |
| K061522 | TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM | Activatek, Inc. | 2006-08-01 | Traditional | PDF ↗ |
| K060814 | DYNATRON ION IONTOPHORESIS ELECTRODE | Dynatronics Corp. | 2006-06-14 | Traditional | PDF ↗ |
| K060579 | COMFORT/IO IONTOPHORESIS ELECTRODES | Pepin Mfg., Inc. | 2006-04-20 | Abbreviated | PDF ↗ |
| K060236 | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE | Iomed, Inc. | 2006-03-31 | Traditional | PDF ↗ |
| K052019 | NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE | North Coast Medical, Inc. | 2005-11-04 | Traditional | PDF ↗ |
| K043047 | DYNATRON IBOX IONTOPHORESIS DEVICE | Dynatronics Corp. | 2005-01-07 | Traditional | PDF ↗ |
| K042590 | TRANSDERM IONTO SYSTEM, MK 2 | Mattioli Engineering Corp. | 2004-10-14 | Traditional | PDF ↗ |
| K041101 | MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 | Medical Adhesiveonline, LLC | 2004-07-07 | Traditional | PDF ↗ |
| K040495 | NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 | Naimco, Inc. | 2004-04-22 | Traditional | PDF ↗ |
| K032968 | TRSANSDERM IONTO SYSTEM | Mattioli Engineering Corp. | 2003-12-02 | Traditional | PDF ↗ |
| K031769 | E-STRIP | Eemso, Inc. | 2003-10-14 | Traditional | PDF ↗ |
| K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 | Selectivemed Components, Inc. | 2003-05-20 | Traditional | PDF ↗ |
| K022950 | MINIPHYSIONIZER 2.0 AND ELECTRODES | Physion, Inc. | 2003-04-18 | Traditional | PDF ↗ |
| K030395 | EMPI ACTION PATCH IONTOPHORESIS SYSTEM | Empi | 2003-04-08 | Traditional | PDF ↗ |
| K020476 | MEDION 6000 | Selectivemed Components, Inc. | 2002-05-03 | Traditional | PDF ↗ |
| K000574 | IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) | Wr Medical Electronics Co. | 2000-08-09 | Traditional | PDF ↗ |
| K993081 | IO-DRIVE | Selectivemed Components, Inc. | 2000-03-03 | Traditional | PDF ↗ |
| K992708 | IONTOPATCH | Birch Point Medical, Inc. | 2000-02-01 | Traditional | PDF ↗ |
| K991991 | DUPEL IONTOPHORESIS SYSTEM | Empi | 1999-09-10 | Traditional | PDF ↗ |
| K982668 | PHORESOR II,MODEL PM900 | Iomed, Inc. | 1999-03-02 | Traditional | PDF ↗ |
| K983484 | DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE | Empi | 1998-12-28 | Traditional | PDF ↗ |
| K970491 | DUPEL II BUFFERED IONTOPHORESIS ELECTRODES | Empi | 1997-05-30 | Traditional | PDF ↗ |
| K964208 | MD-1A GALVANIC UNIT | R. A. Fischer Co. Corp. | 1997-04-30 | Traditional | PDF ↗ |
| K946337 | IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II | Skylark Device Co., Ltd. | 1995-12-20 | Traditional | PDF ↗ |
| K935868 | DYNAPHOR(TM) TWO | Maxxim Medical | 1995-03-15 | Traditional | PDF ↗ |
| K932621 | RH-801/GS MODEL TRANSQ(R)1 | Iomed, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K934335 | PHORESOR II AUTO, MODEL PM800 MODIFICATION | Iomed, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K932620 | RH-806/GS MODEL TRANSQ(R)2 | Iomed, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K915444 | DUPEL IONTOPHORESIS DEVICE | Empi | 1994-07-15 | Traditional | PDF ↗ |
| K913601 | MICROPHOR | Life-Tech Intl., Inc. | 1994-07-15 | Traditional | PDF ↗ |
| K925800 | RH-806, MODEL TRANSQ | Iomed, Inc. | 1994-07-14 | Traditional | PDF ↗ |
| K925806 | RH-801, MODEL TRANSQ | Iomed, Inc. | 1994-07-14 | Traditional | PDF ↗ |
| K914264 | TRANSQ 2 | Iomed, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K914621 | IONTOPHORESIS DEVICE, MODIFICATION | Iomed, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K912015 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 | Empi | 1991-11-15 | Traditional | PDF ↗ |
| K912014 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 | Empi | 1991-10-28 | Traditional | PDF ↗ |
| K903093 | IONTOPHORESIS DEVICE | Empi | 1990-10-11 | Traditional | PDF ↗ |
| K895365 | MD-2 IONTOPHORESIS UNIT | R. A. Fischer Co. Corp. | 1990-06-26 | Traditional | PDF ↗ |
| K896444 | IONTOPHORESIS DEVICE - ELECTRODE RH 800 | Iomed, Inc. | 1990-05-10 | Traditional | PDF ↗ |
| K900363 | NEOPHOR-MC | L.S. Scientific | 1990-04-25 | Traditional | PDF ↗ |
| K896703 | TBD IONTOPHORESIS ELECTRODE | Empi | 1990-02-26 | Traditional | PDF ↗ |
| K894549 | DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE | Henley Intl. | 1990-02-09 | Traditional | PDF ↗ |
| K884834 | XOMED IONESTHETIZER(TM) | Xomed, Inc. | 1989-02-15 | Traditional | PDF ↗ |
| K882554 | MEDITRODE KIT | Life-Tech Intl., Inc. | 1988-12-23 | Traditional | PDF ↗ |
| K871869 | MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI. | Life-Tech Intl., Inc. | 1987-08-11 | Traditional | PDF ↗ |
| K872040 | PHORESOR II (TM), MODEL PM700 | Motion Control, Inc. | 1987-08-04 | Traditional | PDF ↗ |
| K863166 | MODEL 6110 IONTOPHORETIC APPLICATOR | Life-Tech Intl., Inc. | 1987-03-04 | Traditional | PDF ↗ |
| K853635 | SUBDERM TM | General Medical Co. | 1985-12-20 | Traditional | PDF ↗ |
| K850508 | LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES | Kal Life Systems | 1985-05-15 | Traditional | PDF ↗ |
| K842483 | SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC | Santa Barbara Medco, Inc. | 1984-08-31 | Traditional | PDF ↗ |
| K831320 | DRIONIC | General Medical Co. | 1983-07-19 | Traditional | PDF ↗ |
| K770717 | IONTOPHORESIS SYSTEM MODULE, DM 500 | Sorensen Research | 1977-08-15 | Traditional | PDF ↗ |
| K771130 | DESENSITRON | Parker Laboratories, Inc. | 1977-07-15 | Traditional | PDF ↗ |
Product code EGJ · Class II · Physical Medicine. Data: openFDA.