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TPLC
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Device
exerciser, non-measuring
Product Code
ION
Regulation Number
890.5370
Device Class
1
Premarket Reviews
Manufacturer
Decision
IM-ABLE LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
3
3
2016
6
6
2017
3
3
2018
5
5
2019
9
9
2020
6
6
2021
7
7
2022
5
5
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Fragmentation
11
11
Adverse Event Without Identified Device or Use Problem
6
6
Break
5
5
Material Integrity Problem
4
4
Insufficient Information
3
3
Burst Container or Vessel
2
2
Use of Device Problem
2
2
Detachment of Device or Device Component
2
2
Product Quality Problem
2
2
Device Slipped
2
2
Appropriate Term/Code Not Available
2
2
Entrapment of Device
1
1
Mechanical Problem
1
1
Device Contamination with Body Fluid
1
1
Inadequate or Insufficient Training
1
1
Device Reprocessing Problem
1
1
Naturally Worn
1
1
Unintended System Motion
1
1
Loose or Intermittent Connection
1
1
Improper or Incorrect Procedure or Method
1
1
Detachment Of Device Component
1
1
Crack
1
1
Split
1
1
Device Markings/Labelling Problem
1
1
Defective Component
1
1
Material Rupture
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
12
12
No Clinical Signs, Symptoms or Conditions
7
7
Fall
4
4
Eye Injury
4
4
No Information
3
3
Hematoma
3
3
Injury
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Skin Irritation
2
2
Bone Fracture(s)
2
2
Laceration(s)
2
2
Skin Tears
2
2
Hemorrhage/Bleeding
2
2
Damage to Ligament(s)
1
1
Complaint, Ill-Defined
1
1
Hip Fracture
1
1
No Code Available
1
1
Emotional Changes
1
1
Head Injury
1
1
Multiple Fractures
1
1
Rupture
1
1
Foreign Body In Patient
1
1
Concussion
1
1
Swelling
1
1
Erythema
1
1
Limb Fracture
1
1
Loss of consciousness
1
1
Headache
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Amtryke LLC
II
Apr-24-2015
2
North Coast Medical Inc
II
May-14-2012
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