EGJ · Class II · 21 CFR 890.5525

FDA Product Code EGJ: Device, Iontophoresis, Other Uses

Leading manufacturers include Empi, Iomed, Inc. and Life-Tech Intl., Inc..

73
Total
73
Cleared
187d
Avg days
1977
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 214d avg (recent)

FDA 510(k) Cleared Device, Iontophoresis, Other Uses Devices (Product Code EGJ)

73 devices
1–24 of 73
Cleared Apr 01, 2025
STOPWET iontophoresis apparatus (SW01)
K242041
Taiwan Medical Electronics Co., Ltd.
Physical Medicine · 263d
Cleared Oct 17, 2024
Hidroxa SE30
K241267
Hidroxa Medical AB
Physical Medicine · 164d
Cleared Oct 16, 2023
Iontophoresis Electrodes
K232020
Top-Rank Health Care Co., Ltd.
Physical Medicine · 101d
Cleared Feb 10, 2020
Dermadry
K192749
Dermadry Laboratories, Inc.
Physical Medicine · 133d
Cleared Oct 18, 2019
Saalio
K191436
Saalmann Medical GmbH & Co. KG
Physical Medicine · 141d
Cleared Jun 15, 2018
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
K170835
Hightech Development
Physical Medicine · 452d
Cleared May 01, 2017
IontoDC
K170291
Soterix Medical, Inc.
Physical Medicine · 90d
Cleared May 20, 2015
TULA Iontophoresis System with Earset
K150453
Acclarent, Inc.
Physical Medicine · 89d
Cleared Apr 08, 2015
HIDREX PSP1000
K133033
Hidrex GmbH
Physical Medicine · 559d
Cleared Feb 13, 2014
ACTIVAPATCH ET IONTOPHORESIS PATCH
K132832
Activatek, Inc.
Physical Medicine · 156d
Cleared Jun 16, 2011
TULA IONTOPHORESIS SYSTEM
K110636
Acclarent, Inc.
Physical Medicine · 104d
Cleared Jun 16, 2009
ACTHYDERM
K083016
Microlab Americas, Inc.
Physical Medicine · 250d
Cleared May 27, 2009
ACTIVAPATCH
K091326
Activatek, Inc.
Physical Medicine · 22d
Cleared Jun 18, 2008
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
K080580
Axelgaard Mfg. Co., Ltd.
Physical Medicine · 107d
Cleared Mar 05, 2008
IONTOPHORESIS SYSTEM
K073276
Acclarent, Inc.
Physical Medicine · 105d
Cleared Nov 16, 2007
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946
Empi
Physical Medicine · 30d
Cleared May 14, 2007
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427
Empi
Physical Medicine · 90d
Cleared Apr 30, 2007
MESODERM
K061849
Aa Advanced Technology, Inc.
Physical Medicine · 304d
Cleared Mar 01, 2007
ERCHONIA IOTO_240
K062792
Erchonia Medical, Inc.
Physical Medicine · 164d
Cleared Feb 28, 2007
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
K063465
Iomed, Inc.
Physical Medicine · 104d
Cleared Aug 01, 2006
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
K061522
Activatek, Inc.
Physical Medicine · 60d
Cleared Jun 14, 2006
DYNATRON ION IONTOPHORESIS ELECTRODE
K060814
Dynatronics Corp.
Physical Medicine · 79d
Cleared Apr 20, 2006
COMFORT/IO IONTOPHORESIS ELECTRODES
K060579
Pepin Mfg., Inc.
Physical Medicine · 45d
Cleared Mar 31, 2006
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
K060236
Iomed, Inc.
Physical Medicine · 60d

About Product Code EGJ - Regulatory Context

510(k) Submission Activity

73 total 510(k) submissions under product code EGJ since 1977, with 73 receiving FDA clearance (average review time: 187 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EGJ Product Code

FDA review times for EGJ submissions have been consistent, averaging 214 days recently vs 187 days historically.

EGJ devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →