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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wheelchair, mechanical
Product CodeIOR
Regulation Number 890.3850
Device Class 1


Premarket Reviews
ManufacturerDecision
BRODA SEATING (BRODA LP)
  SUBSTANTIALLY EQUIVALENT 1
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HORIZON MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JUMAO MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGYIN NEWRISE MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KI MOBILITY LLC
  SUBSTANTIALLY EQUIVALENT 2
LEGGERO LLC
  SUBSTANTIALLY EQUIVALENT 1
MOBILITY SOURCE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
PANTHERA AB
  SUBSTANTIALLY EQUIVALENT 1
POWER PLUS MOBILITY
  SUBSTANTIALLY EQUIVALENT 1
RGK WHEELCHAIRS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROUGHRIDER AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
ROWHEELS INC.
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN AST MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 53 53
2020 43 43
2021 59 59
2022 37 37
2023 165 165
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 65 65
Break 34 34
Adverse Event Without Identified Device or Use Problem 33 33
Insufficient Information 26 26
Mechanical Problem 26 26
Appropriate Term/Code Not Available 22 22
Use of Device Problem 20 20
Defective Component 17 17
Fracture 12 12
Device Slipped 9 9
Material Integrity Problem 9 9
Mechanics Altered 9 9
Sharp Edges 9 9
Unintended Movement 8 8
Improper or Incorrect Procedure or Method 7 7
Human-Device Interface Problem 6 6
Component Missing 6 6
Solder Joint Fracture 5 5
Material Split, Cut or Torn 5 5
Misassembly by Users 4 4
Material Twisted/Bent 4 4
Installation-Related Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Loose or Intermittent Connection 4 4
Product Quality Problem 3 3
Material Fragmentation 3 3
Device Tipped Over 3 3
Protective Measures Problem 3 3
Patient Device Interaction Problem 3 3
Device Fell 3 3
Misassembly During Maintenance/Repair 3 3
Misassembled During Installation 2 2
Physical Resistance/Sticking 2 2
Scratched Material 2 2
Compatibility Problem 2 2
Device Unsafe to Use in Environment 2 2
Fail-Safe Problem 2 2
Unstable 2 2
Electromagnetic Interference 2 2
Entrapment of Device 2 2
Crack 2 2
Unintended System Motion 2 2
Material Separation 2 2
Difficult to Fold, Unfold or Collapse 2 2
Misassembled 1 1
Retraction Problem 1 1
Degraded 1 1
Disconnection 1 1
Fire 1 1
Inadequate Instructions for Healthcare Professional 1 1
Inadequate or Insufficient Training 1 1
Separation Failure 1 1
Defective Device 1 1
Inadequate User Interface 1 1
Connection Problem 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Unclear Information 1 1
Missing Information 1 1
Unintended Deflation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
Insufficient Information 77 77
Bone Fracture(s) 64 64
Fall 56 56
Laceration(s) 47 47
Head Injury 15 15
Bruise/Contusion 13 13
Limb Fracture 10 10
Death 9 9
Abrasion 8 8
Pain 8 8
Hematoma 6 6
Injury 5 5
Hip Fracture 5 5
Pressure Sores 4 4
Brain Injury 4 4
Crushing Injury 4 4
Swelling/ Edema 4 4
Loss of consciousness 3 3
Tooth Fracture 3 3
Post Traumatic Wound Infection 3 3
No Known Impact Or Consequence To Patient 3 3
Damage to Ligament(s) 3 3
Burn(s) 2 2
Joint Dislocation 2 2
Spinal Column Injury 2 2
Tissue Damage 2 2
Concussion 2 2
Multiple Fractures 2 2
Muscle/Tendon Damage 2 2
Neck Stiffness 2 2
Easy Bruising 2 2
Unspecified Tissue Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Musculoskeletal problem 1 1
Skin Infection 1 1
Neck Pain 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Hyperextension 1 1
Suture Abrasion 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
Confusion/ Disorientation 1 1
Nervous System Injury 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Syncope/Fainting 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Respiratory Problem 1 1
Rupture 1 1
Strangulation 1 1
Skin Erosion 1 1
Skin Irritation 1 1
Skull Fracture 1 1
Inadequate Pain Relief 1 1
Fracture, Arm 1 1
Myalgia 1 1
Abscess 1 1
Abdominal Pain 1 1
Non specific EKG/ECG Changes 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Intracranial Hemorrhage 1 1
High Blood Pressure/ Hypertension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 TiSport, Llc II Nov-18-2021
2 TiSport, Llc II Aug-20-2019
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