TPLC - Total Product Life Cycle

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Device	system, isokinetic testing and evaluation
Product Code	IKK
Regulation Number	890.1925
Device Class	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
Break	2	2
Mechanical Problem	2	2
Melted	2	2
Improper or Incorrect Procedure or Method	2	2
Device Operates Differently Than Expected	2	2
Temperature Problem	1	1
Device Handling Problem	1	1
Patient Device Interaction Problem	1	1
Unintended System Motion	1	1
Loss of Power	1	1
Difficult to Remove	1	1
Smoking	1	1
Use of Device Problem	1	1
Degraded	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 Clinical Signs, Symptoms or Conditions	4	4
No Consequences Or Impact To Patient	3	3
Bone Fracture(s)	2	2
Pain	2	2
Skin Discoloration	1	1
Tissue Damage	1	1
Hematoma	1	1
Bruise/Contusion	1	1
Edema	1	1
Pressure Sores	1	1
Discomfort	1	1
Injury	1	1
Impaired Healing	1	1
Neck Pain	1	1
No Patient Involvement	1	1
No Code Available	1	1
Cancer	1	1
Limb Fracture	1	1
Hyperextension	1	1
Joint Laxity	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	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