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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device exerciser, non-measuring
Product CodeION
Regulation Number 890.5370
Device Class 1


Premarket Reviews
ManufacturerDecision
IM-ABLE LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K120783  ABLE-X

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
Appropriate Term/Code Not Available 2 2
Detachment of Device or Device Component 2 2
Burst Container or Vessel 2 2
Product Quality Problem 2 2
Device Slipped 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Split 1 1
Inadequate or Insufficient Training 1 1
Material Rupture 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1
Crack 1 1
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Unintended System Motion 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Naturally Worn 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
Eye Injury 4 4
Fall 4 4
Hematoma 3 3
Injury 3 3
No Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Skin Tears 2 2
Skin Irritation 2 2
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Bone Fracture(s) 2 2
Head Injury 1 1
Headache 1 1
Damage to Ligament(s) 1 1
Swelling 1 1
Concussion 1 1
Rupture 1 1
Complaint, Ill-Defined 1 1
Hip Fracture 1 1
Loss of consciousness 1 1
Bruise/Contusion 1 1
Emotional Changes 1 1
Erythema 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Limb Fracture 1 1
Multiple Fractures 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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