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TPLC
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Device
system, isokinetic testing and evaluation
Product Code
IKK
Regulation Number
890.1925
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMES TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
7
7
2017
2
2
2019
2
2
2020
1
1
2021
1
1
2022
3
3
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
5
5
Device Displays Incorrect Message
3
3
Mechanical Problem
2
2
Break
2
2
Device Operates Differently Than Expected
2
2
Melted
2
2
Improper or Incorrect Procedure or Method
2
2
Patient Device Interaction Problem
1
1
Difficult to Remove
1
1
Use of Device Problem
1
1
Device Handling Problem
1
1
Patient-Device Incompatibility
1
1
Smoking
1
1
Degraded
1
1
Unintended System Motion
1
1
Loss of Power
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4
4
No Known Impact Or Consequence To Patient
4
4
No Consequences Or Impact To Patient
3
3
Bone Fracture(s)
2
2
Pain
2
2
Impaired Healing
1
1
No Code Available
1
1
Hematoma
1
1
Edema
1
1
Skin Discoloration
1
1
Neck Pain
1
1
Injury
1
1
No Patient Involvement
1
1
Discomfort
1
1
Hyperextension
1
1
Muscle/Tendon Damage
1
1
Limb Fracture
1
1
Joint Laxity
1
1
Unspecified Tissue Injury
1
1
Tissue Damage
1
1
Cancer
1
1
Pressure Sores
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hocoma AG
II
Jun-23-2020
2
Interactive Motion Technologies, Inc.
II
Nov-02-2015
3
MedX Holdings, Inc.
II
Jan-07-2015
4
Trexo Robotics Holdings Inc.
II
Jul-25-2023
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