Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
device, iontophoresis, other uses
Product Code
EGJ
Regulation Number
890.5525
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACCLARENT, INC.
SUBSTANTIALLY EQUIVALENT
2
ACTIVATEK INC.
SUBSTANTIALLY EQUIVALENT
2
DERMADRY LABORATORIES INC.
SUBSTANTIALLY EQUIVALENT
1
HIDREX GMBH
SUBSTANTIALLY EQUIVALENT
1
HIGHTECH DEVELOPMENT
SUBSTANTIALLY EQUIVALENT
1
1. K170835
Electro Antiperspirant, Electro Antiperspirant Sen
...
MICROLAB AMERICAS INC
SUBSTANTIALLY EQUIVALENT
1
SAALMANN MEDICAL GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
SOTERIX MEDICAL,INC.
SUBSTANTIALLY EQUIVALENT
1
TOP-RANK HEALTH CARE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
2
2
2016
3
3
2017
3
3
2018
8
8
2019
2
2
2020
2
2
2022
1
1
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
7
7
Adverse Event Without Identified Device or Use Problem
5
5
Insufficient Information
5
5
Temperature Problem
1
1
Device Operates Differently Than Expected
1
1
Material Protrusion/Extrusion
1
1
Component Incompatible
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Skin Irritation
8
8
Full thickness (Third Degree) Burn
5
5
Burn, Thermal
3
3
Burn(s)
3
3
Dizziness
2
2
Partial thickness (Second Degree) Burn
2
2
Viral Infection
1
1
Discomfort
1
1
Malaise
1
1
Numbness
1
1
Post Traumatic Wound Infection
1
1
Sleep Dysfunction
1
1
Fatigue
1
1
Pain
1
1
Rash
1
1
Skin Discoloration
1
1
Cognitive Changes
1
1
Tinnitus
1
1
Convulsion/Seizure
1
1
Epilepsy
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Blister
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hidrex GmbH
III
Feb-22-2017
2
Tapemark Company
III
Jan-05-2022
-
-