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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device wheelchair, mechanical
Regulation Description Mechanical wheelchair.
Product CodeIOR
Regulation Number 890.3850
Device Class 1


Premarket Reviews
ManufacturerDecision
BOWHEAD DESIGN CORP.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN SHUNKANGDA MEDICAL TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KI MOBILITY LLC
  SUBSTANTIALLY EQUIVALENT 2
LICHTMEGA TECHNOLOGY CO., LTD.
  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
SICHUAN AST MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN AST MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TURBO WHEELCHAIR CO., INC.
  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
2020 43 43
2021 59 59
2022 37 37
2023 165 165
2024 138 138
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 139 139
Mechanical Problem 32 32
Appropriate Term/Code Not Available 32 32
Break 27 27
Insufficient Information 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Use of Device Problem 19 19
Defective Component 17 17
Sharp Edges 10 10
Fracture 9 9
Mechanics Altered 9 9
Material Integrity Problem 9 9
Unintended Movement 7 7
Device Slipped 6 6
Human-Device Interface Problem 6 6
Component Missing 6 6
Improper or Incorrect Procedure or Method 5 5
Loose or Intermittent Connection 4 4
Installation-Related Problem 4 4
Solder Joint Fracture 4 4
Misassembly by Users 4 4
Device Tipped Over 3 3
Material Twisted/Bent 3 3
Material Split, Cut or Torn 3 3
Patient Device Interaction Problem 3 3
Scratched Material 2 2
Physical Resistance/Sticking 2 2
Device Unsafe to Use in Environment 2 2
Material Separation 2 2
Fail-Safe Problem 2 2
Product Quality Problem 2 2
Unintended System Motion 2 2
Misassembled During Installation 2 2
Difficult to Fold, Unfold or Collapse 2 2
Material Fragmentation 2 2
Compatibility Problem 2 2
Electromagnetic Interference 2 2
Unstable 2 2
Protective Measures Problem 2 2
Defective Device 1 1
Device Fell 1 1
Misassembly During Maintenance/Repair 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Accessory Incompatible 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Inadequate User Interface 1 1
Inadequacy of Device Shape and/or Size 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 163 163
Insufficient Information 84 84
Bone Fracture(s) 54 54
Fall 46 46
Laceration(s) 40 40
Head Injury 14 14
Bruise/Contusion 13 13
Limb Fracture 11 11
Pain 9 9
Abrasion 8 8
Swelling/ Edema 6 6
Hematoma 6 6
Hip Fracture 5 5
Death 5 5
Brain Injury 5 5
Unspecified Musculoskeletal problem 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Crushing Injury 3 3
Loss of consciousness 3 3
Tooth Fracture 3 3
Pressure Sores 3 3
Unspecified Tissue Injury 2 2
Multiple Fractures 2 2
Easy Bruising 2 2
Concussion 2 2
Hemorrhage/Bleeding 2 2
Post Traumatic Wound Infection 2 2
Neck Stiffness 2 2
Hyperextension 2 2
Damage to Ligament(s) 2 2
Muscle/Tendon Damage 2 2
Skin Tears 2 2
Burn(s) 2 2
Full thickness (Third Degree) Burn 1 1
Myalgia 1 1
Abscess 1 1
Strangulation 1 1
Headache 1 1
Confusion/ Disorientation 1 1
Skin Irritation 1 1
Skin Erosion 1 1
Suture Abrasion 1 1
Syncope/Fainting 1 1
Partial thickness (Second Degree) Burn 1 1
Intracranial Hemorrhage 1 1
Unspecified Infection 1 1
No Code Available 1 1
Joint Dislocation 1 1
Inadequate Pain Relief 1 1
Skull Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 TiSport, Llc II Nov-18-2021
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