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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
DANYANG SUNTEC AUTO PARTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FREE WHEELCHAIR MISSION
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
JIANGSU JUMAO MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MOTION COMPOSITES
  SUBSTANTIALLY EQUIVALENT 1
PROACTIVE COMFORT, LLC
  SUBSTANTIALLY EQUIVALENT 1
R82 A/S
  SUBSTANTIALLY EQUIVALENT 1
RGK WHEELCHAIRS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
RUPIANI
  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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 842 842
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 55 55
Naturally Worn 55 55
Adverse Event Without Identified Device or Use Problem 41 41
Component Falling 39 39
Loose or Intermittent Connection 37 37
Material Integrity Problem 37 37
Component Missing 27 27
Mechanics Altered 25 25
Unstable 21 21
Device Dislodged or Dislocated 21 21
Use of Device Problem 19 19
Device Tipped Over 18 18
Unintended Movement 18 18
Stretched 17 17
Material Separation 15 15
Insufficient Information 15 15
Split 13 13
Fracture 13 13
Device Inoperable 13 13
Improper or Incorrect Procedure or Method 12 12
Appropriate Term/Code Not Available 10 10
Noise, Audible 7 7
Defective Device 7 7
Sticking 7 7
Malposition of Device 7 7
Inadequacy of Device Shape and/or Size 6 6
Collapse 6 6
Material Split, Cut or Torn 5 5
Patient-Device Incompatibility 5 5
Material Twisted/Bent 5 5
Scratched Material 5 5
Unintended System Motion 4 4
Failure to Align 4 4
Hole In Material 4 4
Folded 3 3
Out-Of-Box Failure 3 3
Installation-Related Problem 3 3
Product Quality Problem 3 3
Misassembled 3 3
Entrapment of Device 3 3
Solder Joint Fracture 3 3
Fitting Problem 3 3
Misassembly During Maintenance/Repair 3 3
Sharp Edges 2 2
Device Fell 2 2
Positioning Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure To Adhere Or Bond 2 2
Device Maintenance Issue 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 2 2
Protective Measures Problem 2 2
Device Handling Problem 2 2
Loss of Power 2 2
Inadequate or Insufficient Training 2 2
Material Fragmentation 2 2
Material Disintegration 2 2
Loss of or Failure to Bond 2 2
Burst Container or Vessel 1 1
Unintended Ejection 1 1
Fire 1 1
Fluid Leak 1 1
Inadequate Instructions for Healthcare Professional 1 1
Migration or Expulsion of Device 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Plunge 1 1
Smoking 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Patient Device Interaction Problem 1 1
Misassembled During Installation 1 1
Unclear Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Physical Property Issue 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Protrusion/Extrusion 1 1
Failure to Shut Off 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Unintended Collision 1 1
Self-Activation or Keying 1 1
Device Alarm System 1 1
Partial Blockage 1 1
Thermal Decomposition of Device 1 1
Fail-Safe Design Failure 1 1
Material Frayed 1 1
Corroded 1 1
Electrical /Electronic Property Problem 1 1
Material Distortion 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1738 1738
Fall 103 103
Bone Fracture(s) 70 70
No Information 42 42
Injury 36 36
Laceration(s) 34 34
Head Injury 24 24
Bruise/Contusion 19 19
Pain 17 17
Death 10 10
No Consequences Or Impact To Patient 10 10
Hip Fracture 8 8
Abrasion 6 6
Fracture, Arm 5 5
Tissue Damage 5 5
No Code Available 5 5
Discomfort 4 4
Tooth Fracture 4 4
Brain Injury 4 4
Physical Entrapment 4 4
Insufficient Information 4 4
Crushing Injury 3 3
Joint Dislocation 3 3
Pressure Sores 3 3
Swelling 3 3
Hematoma 3 3
Headache 3 3
Hemorrhage/Bleeding 3 3
Post Traumatic Wound Infection 3 3
No Patient Involvement 3 3
Suture Abrasion 2 2
Limb Fracture 2 2
Complaint, Ill-Defined 2 2
Contusion 2 2
Damage to Ligament(s) 2 2
Loss of consciousness 2 2
Skin Tears 2 2
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Spinal Cord Injury 1 1
Hypoesthesia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Loss of Range of Motion 1 1
Skin Erosion 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Thrombus 1 1
Vertigo 1 1
Concussion 1 1
Burn(s) 1 1
Seizures 1 1
Skull Fracture 1 1
Anxiety 1 1
Weakness 1 1
Ecchymosis 1 1
Choking 1 1
Arthralgia 1 1
Disability 1 1
Inadequate Pain Relief 1 1
Obstruction/Occlusion 1 1
Swelling/ Edema 1 1
Vascular System (Circulation), Impaired 1 1
Alteration In Body Temperature 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 Aug-20-2019
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