Panels › Physical Medicine › Product code EGJ · Class 2
Device, Iontophoresis, Other Uses
Regulation 890.5525
0510(k)s in 12 months (73 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in EGJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Empi | 11 | 0 |
| Iomed, Inc. | 11 | 0 |
| Hidrex GmbH | 1 | 3 |
| Life-Tech Intl., Inc. | 4 | 0 |
| Selectivemed Components, Inc. | 3 | 1 |
| Acclarent, Inc. | 3 | 0 |
| Activatek, Inc. | 3 | 0 |
| Dynatronics Corp. | 2 | 0 |
| General Medical Co. | 2 | 0 |
| LTS Therapy Systems, LLC | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 1, 2025 | K242041 | STOPWET iontophoresis apparatus (SW01) Taiwan Medical Electronics Co., Ltd., TW | EGJ |
| Oct 17, 2024 | K241267 | Hidroxa SE30 Hidroxa Medical AB, SE | EGJ |
| Oct 16, 2023 | K232020 | Iontophoresis Electrodes Top-Rank Health Care Co., Ltd., CN | EGJ |
| Feb 10, 2020 | K192749 | Dermadry Dermadry Laboratories, Inc., CA | EGJ |
| Oct 18, 2019 | K191436 | Saalio Saalmann Medical GmbH & Co. KG, DE | EGJ |
| Jun 15, 2018 | K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE Hightech Development, CZ | EGJ |
| May 1, 2017 | K170291 | IontoDC Soterix Medical, Inc. | EGJ |
| May 20, 2015 | K150453 | TULA Iontophoresis System with Earset Acclarent, Inc. | EGJ |
| Apr 8, 2015 | K133033 | HIDREX PSP1000 Hidrex GmbH | EGJ |
| Feb 13, 2014 | K132832 | ACTIVAPATCH ET IONTOPHORESIS PATCH Activatek, Inc. | EGJ |
| Jun 16, 2011 | K110636 | TULA IONTOPHORESIS SYSTEM Acclarent, Inc. | EGJ |
| Jun 16, 2009 | K083016 | ACTHYDERM Microlab Americas, Inc. | EGJ |
| May 27, 2009 | K091326 | ACTIVAPATCH Activatek, Inc. | EGJ |
| Jun 18, 2008 | K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D Axelgaard Mfg. Co., Ltd. | EGJ |
| Mar 5, 2008 | K073276 | IONTOPHORESIS SYSTEM Acclarent, Inc. | EGJ |
| Nov 16, 2007 | K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM Empi | EGJ |
| May 14, 2007 | K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM Empi | EGJ |
| Apr 30, 2007 | K061849 | MESODERM Aa Advanced Technology, Inc. | EGJ |
| Mar 1, 2007 | K062792 | ERCHONIA IOTO_240 Erchonia Medical, Inc. | EGJ |
| Feb 28, 2007 | K063465 | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE Iomed, Inc. | EGJ |
| Aug 1, 2006 | K061522 | TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM Activatek, Inc. | EGJ |
| Jun 14, 2006 | K060814 | DYNATRON ION IONTOPHORESIS ELECTRODE Dynatronics Corp. | EGJ |
| Apr 20, 2006 | K060579 | COMFORT/IO IONTOPHORESIS ELECTRODES Pepin Mfg., Inc. | EGJ |
| Mar 31, 2006 | K060236 | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE Iomed, Inc. | EGJ |
| Nov 4, 2005 | K052019 | NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE North Coast Medical, Inc. | EGJ |
| Jan 7, 2005 | K043047 | DYNATRON IBOX IONTOPHORESIS DEVICE Dynatronics Corp. | EGJ |
| Oct 14, 2004 | K042590 | TRANSDERM IONTO SYSTEM, MK 2 Mattioli Engineering Corp. | EGJ |
| Jul 7, 2004 | K041101 | MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 Medical Adhesiveonline, LLC | EGJ |
| Apr 22, 2004 | K040495 | NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 Naimco, Inc. | EGJ |
| Dec 2, 2003 | K032968 | TRSANSDERM IONTO SYSTEM Mattioli Engineering Corp. | EGJ |
| Oct 14, 2003 | K031769 | E-STRIP Eemso, Inc. | EGJ |
| May 20, 2003 | K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 Selectivemed Components, Inc. | EGJ |
| Apr 18, 2003 | K022950 | MINIPHYSIONIZER 2.0 AND ELECTRODES Physion, Inc. | EGJ |
| Apr 8, 2003 | K030395 | EMPI ACTION PATCH IONTOPHORESIS SYSTEM Empi | EGJ |
| May 3, 2002 | K020476 | MEDION 6000 Selectivemed Components, Inc. | EGJ |
| Aug 9, 2000 | K000574 | IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) Wr Medical Electronics Co. | EGJ |
| Mar 3, 2000 | K993081 | IO-DRIVE Selectivemed Components, Inc. | EGJ |
| Feb 1, 2000 | K992708 | IONTOPATCH Birch Point Medical, Inc. | EGJ |
| Sep 10, 1999 | K991991 | DUPEL IONTOPHORESIS SYSTEM Empi | EGJ |
| Mar 2, 1999 | K982668 | PHORESOR II,MODEL PM900 Iomed, Inc. | EGJ |
| Dec 28, 1998 | K983484 | DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE Empi | EGJ |
| May 30, 1997 | K970491 | DUPEL II BUFFERED IONTOPHORESIS ELECTRODES Empi | EGJ |
| Apr 30, 1997 | K964208 | MD-1A GALVANIC UNIT R. A. Fischer Co. Corp. | EGJ |
| Dec 20, 1995 | K946337 | IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II Skylark Device Co., Ltd., TW | EGJ |
| Mar 15, 1995 | K935868 | DYNAPHOR(TM) TWO Maxxim Medical | EGJ |
| Jul 26, 1994 | K934335 | PHORESOR II AUTO, MODEL PM800 MODIFICATION Iomed, Inc. | EGJ |
| Jul 26, 1994 | K932621 | RH-801/GS MODEL TRANSQ(R)1 Iomed, Inc. | EGJ |
| Jul 26, 1994 | K932620 | RH-806/GS MODEL TRANSQ(R)2 Iomed, Inc. | EGJ |
| Jul 15, 1994 | K915444 | DUPEL IONTOPHORESIS DEVICE Empi | EGJ |
| Jul 15, 1994 | K913601 | MICROPHOR Life-Tech Intl., Inc. | EGJ |
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