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TPLC
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Device
exerciser, non-measuring
Regulation Description
Nonmeasuring exercise equipment.
Product Code
ION
Regulation Number
890.5370
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
6
6
2021
7
7
2022
5
5
2023
2
2
2024
1
1
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Fragmentation
7
7
Insufficient Information
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Break
3
3
Use of Device Problem
1
1
Defective Component
1
1
Improper or Incorrect Procedure or Method
1
1
Loose or Intermittent Connection
1
1
Crack
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7
7
Fall
2
2
Limb Fracture
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Injury
1
1
Joint Dislocation
1
1
Bruise/Contusion
1
1
Emotional Changes
1
1
Erythema
1
1
Eye Injury
1
1
Headache
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
Multiple Fractures
1
1
Foreign Body In Patient
1
1
No Known Impact Or Consequence To Patient
1
1
Laceration(s)
1
1
Pain
1
1
Pneumothorax
1
1
Loss of Range of Motion
1
1
Skin Irritation
1
1
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