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
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
Back to Search Results
Device
system, isokinetic testing and evaluation
Regulation Description
Isokinetic testing and evaluation system.
Product Code
IKK
Regulation Number
890.1925
Device Class
2
MDR Year
MDR Reports
MDR Events
2016
7
7
2017
2
2
2019
2
2
2020
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
3
3
Device Operates Differently Than Expected
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Break
2
2
Mechanical Problem
1
1
Loss of Power
1
1
Difficult to Remove
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Temperature Problem
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
4
4
No Consequences Or Impact To Patient
3
3
Pressure Sores
1
1
Neck Pain
1
1
Hematoma
1
1
Skin Discoloration
1
1
Bruise/Contusion
1
1
Edema
1
1
Pain
1
1
Tissue Damage
1
1
Discomfort
1
1
Injury
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hocoma AG
II
Jun-23-2020
-
-