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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wheelchair, mechanical
Regulation Description Mechanical wheelchair.
Product CodeIOR
Regulation Number 890.3850
Device Class 1


Premarket Reviews
ManufacturerDecision
BRODA SEATING (BRODA LP)
  SUBSTANTIALLY EQUIVALENT 1
CONVAID PRODUCTS LLC.
  SUBSTANTIALLY EQUIVALENT 1
DANYANG SUNCO MACHINERY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DANYANG SUNTEC AUTO PARTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FREE WHEELCHAIR MISSION
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
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
KUNSHAN HI-FORTUNE HEALTH PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEGGERO LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL REHAB PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERITS HEALTHCARE INDUSTRIES (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOTION COMPOSITES
  SUBSTANTIALLY EQUIVALENT 1
NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PDG PRODUCT DESIGN GROUP, INC
  SUBSTANTIALLY EQUIVALENT 1
PROACTIVE COMFORT, LLC
  SUBSTANTIALLY EQUIVALENT 1
R82 A/S
  SUBSTANTIALLY EQUIVALENT 1
RGK WHEELCHAIRS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROWHEELS INC.
  SUBSTANTIALLY EQUIVALENT 1
RUPIANI
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN AST MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WINNER SG PTE LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1860 1860
2017 49 49
2018 58 58
2019 53 53
2020 43 43
2021 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Break 845 845
Bent 200 200
Crack 135 135
Mechanical Problem 126 126
Device Operates Differently Than Expected 99 99
Material Deformation 99 99
Device Slipped 89 89
Detachment Of Device Component 82 82
Torn Material 69 69
Detachment of Device or Device Component 58 58
Naturally Worn 55 55
Adverse Event Without Identified Device or Use Problem 48 48
Component Falling 39 39
Loose or Intermittent Connection 38 38
Material Integrity Problem 37 37
Component Missing 27 27
Mechanics Altered 25 25
Insufficient Information 21 21
Unstable 21 21
Use of Device Problem 21 21
Device Dislodged or Dislocated 21 21
Device Tipped Over 18 18
Unintended Movement 18 18
Stretched 17 17
Fracture 17 17
Appropriate Term/Code Not Available 16 16
Material Separation 15 15
Device Inoperable 13 13
Split 13 13
Improper or Incorrect Procedure or Method 12 12
Sticking 7 7
Defective Device 7 7
Malposition of Device 7 7
Noise, Audible 7 7
Material Twisted/Bent 7 7
Inadequacy of Device Shape and/or Size 6 6
Collapse 6 6
Patient-Device Incompatibility 5 5
Scratched Material 5 5
Material Split, Cut or Torn 5 5
Sharp Edges 5 5
Installation-Related Problem 4 4
Failure to Align 4 4
Solder Joint Fracture 4 4
Unintended System Motion 4 4
Hole In Material 4 4
Misassembled 3 3
Product Quality Problem 3 3
Entrapment of Device 3 3
Out-Of-Box Failure 3 3
Fitting Problem 3 3
Folded 3 3
Misassembly by Users 3 3
Misassembly During Maintenance/Repair 3 3
Device Fell 2 2
Device Handling Problem 2 2
No Apparent Adverse Event 2 2
Positioning Problem 2 2
Protective Measures Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Loss of Power 2 2
Inadequate or Insufficient Training 2 2
Material Disintegration 2 2
Loss of or Failure to Bond 2 2
Failure To Adhere Or Bond 2 2
Material Fragmentation 2 2
Device Maintenance Issue 2 2
Migration or Expulsion of Device 1 1
Material Frayed 1 1
Inadequate Instructions for Healthcare Professional 1 1
Self-Activation or Keying 1 1
Device Emits Odor 1 1
Unintended Collision 1 1
Overheating of Device 1 1
Plunge 1 1
Device Alarm System 1 1
Partial Blockage 1 1
Thermal Decomposition of Device 1 1
Burst Container or Vessel 1 1
Electrical /Electronic Property Problem 1 1
Corroded 1 1
Fail-Safe Design Failure 1 1
Unintended Ejection 1 1
Fire 1 1
Fluid Leak 1 1
Unraveled Material 1 1
Device Stops Intermittently 1 1
Smoking 1 1
Defective Component 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Connection Problem 1 1
Extrusion 1 1
Facilities Issue 1 1
Failure to Shut Off 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Unsafe to Use in Environment 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1738 1738
Fall 107 107
Bone Fracture(s) 79 79
No Information 42 42
Laceration(s) 41 41
Injury 36 36
Head Injury 24 24
Bruise/Contusion 22 22
Pain 18 18
Abrasion 10 10
Death 10 10
No Consequences Or Impact To Patient 10 10
Hip Fracture 8 8
Fracture, Arm 5 5
No Code Available 5 5
Insufficient Information 5 5
Brain Injury 5 5
Tissue Damage 5 5
Physical Entrapment 4 4
Discomfort 4 4
Headache 4 4
Hematoma 4 4
Limb Fracture 4 4
Tooth Fracture 4 4
Post Traumatic Wound Infection 3 3
Joint Dislocation 3 3
No Patient Involvement 3 3
Hemorrhage/Bleeding 3 3
Crushing Injury 3 3
Pressure Sores 3 3
Swelling 3 3
Complaint, Ill-Defined 2 2
Burn(s) 2 2
Contusion 2 2
Damage to Ligament(s) 2 2
Swelling/ Edema 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Loss of consciousness 2 2
Suture Abrasion 2 2
Skin Tears 2 2
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Vascular System (Circulation), Impaired 1 1
Choking 1 1
Spinal Cord Injury 1 1
Neck Stiffness 1 1
Obstruction/Occlusion 1 1
Inadequate Pain Relief 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Disability 1 1
Alteration In Body Temperature 1 1
Nervous System Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hyperextension 1 1
Unspecified Musculoskeletal problem 1 1
Easy Bruising 1 1
Unspecified Tissue Injury 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Loss of Range of Motion 1 1
Seizures 1 1
Skin Erosion 1 1
Skin Irritation 1 1
Skull Fracture 1 1
Spinal Column Injury 1 1
Abscess 1 1
Anxiety 1 1
Myalgia 1 1
Thrombus 1 1
Ecchymosis 1 1
Vertigo 1 1
Weakness 1 1
Concussion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Karman Healthcare Inc II Feb-27-2016
2 Sunrise Medical (US) LLC II Jul-25-2016
3 TiSport, Llc II Nov-18-2021
4 TiSport, Llc II Aug-20-2019
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