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
components, wheelchair
Product Code
KNN
Regulation Number
890.3920
Device Class
1
Premarket Reviews
Manufacturer
Decision
KINETIC INNOVATIVE SEATING SYSTEM LLC
SUBSTANTIALLY EQUIVALENT
1
1. K211919
KISS Dynamic Back Support, KISS Dynamic Solid Drop
...
MDR Year
MDR Reports
MDR Events
2014
64
64
2015
3
3
2016
2
2
2017
3
3
2018
4
4
2019
2
2
2020
1
1
2021
16
16
2022
3
3
2023
2
2
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
42
42
Appropriate Term/Code Not Available
10
10
Device Operates Differently Than Expected
9
9
Insufficient Information
8
8
Sticking
5
5
Product Quality Problem
4
4
Degraded
3
3
Fluid/Blood Leak
2
2
Detachment Of Device Component
2
2
Unstable
2
2
Bent
2
2
Crack
2
2
Detachment of Device or Device Component
2
2
Improper or Incorrect Procedure or Method
2
2
Material Integrity Problem
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Positioning Problem
1
1
Torn Material
1
1
Misassembly by Users
1
1
Component Missing
1
1
Solder Joint Fracture
1
1
Failure to Advance
1
1
Material Deformation
1
1
Use of Device Problem
1
1
Material Rupture
1
1
Shipping Damage or Problem
1
1
Device Slipped
1
1
Component Falling
1
1
Collapse
1
1
Difficult to Fold, Unfold or Collapse
1
1
Gel Leak
1
1
Loose or Intermittent Connection
1
1
Mechanical Problem
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
35
35
No Consequences Or Impact To Patient
25
25
Pressure Sores
17
17
No Information
10
10
Fall
6
6
Injury
4
4
Ulcer
1
1
Bone Fracture(s)
1
1
Head Injury
1
1
Concussion
1
1
Insufficient Information
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aquila Corporation
II
Sep-18-2023
2
Permobil Inc
II
Mar-22-2012
3
mo-Vis BVBA
II
Jan-11-2024
-
-