EGJ · Class II · 21 CFR 890.5525

FDA Product Code EGJ: Device, Iontophoresis, Other Uses

Leading manufacturers include Empi, Life-Tech Intl., Inc. and Acclarent, 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 20, 2015
TULA Iontophoresis System with Earset
K150453
Acclarent, Inc.
Physical Medicine · 89d
Cleared Jun 16, 2011
TULA IONTOPHORESIS SYSTEM
K110636
Acclarent, Inc.
Physical Medicine · 104d
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 08, 2003
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395
Empi
Physical Medicine · 62d
Cleared Sep 10, 1999
DUPEL IONTOPHORESIS SYSTEM
K991991
Empi
Physical Medicine · 88d
Cleared Dec 28, 1998
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K983484
Empi
Physical Medicine · 84d
Cleared May 30, 1997
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K970491
Empi
Physical Medicine · 109d
Cleared Jul 15, 1994
MICROPHOR
K913601
Life-Tech Intl., Inc.
Physical Medicine · 1067d
Cleared Jul 15, 1994
DUPEL IONTOPHORESIS DEVICE
K915444
Empi
Physical Medicine · 953d
Cleared Nov 15, 1991
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
K912015
Empi
Physical Medicine · 193d
Cleared Oct 28, 1991
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
K912014
Empi
Physical Medicine · 175d
Cleared Oct 11, 1990
IONTOPHORESIS DEVICE
K903093
Empi
Physical Medicine · 90d
Cleared Feb 26, 1990
TBD IONTOPHORESIS ELECTRODE
K896703
Empi
Physical Medicine · 90d
Cleared Feb 09, 1990
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K894549
Henley Intl.
Physical Medicine · 204d
Cleared Feb 15, 1989
XOMED IONESTHETIZER(TM)
K884834
Xomed, Inc.
Physical Medicine · 89d
Cleared Dec 23, 1988
MEDITRODE KIT
K882554
Life-Tech Intl., Inc.
Physical Medicine · 185d

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 →