Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
INVACARE CORPORATION
  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
MEDICAL REHAB PRODUCTS, 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 2
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 58 58
2019 53 53
2020 43 43
2021 59 59
2022 37 37
2023 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 48 48
Break 43 43
Adverse Event Without Identified Device or Use Problem 41 41
Insufficient Information 29 29
Mechanical Problem 25 25
Use of Device Problem 23 23
Defective Component 17 17
Appropriate Term/Code Not Available 17 17
Fracture 12 12
Unintended Movement 10 10
Material Integrity Problem 10 10
Mechanics Altered 8 8
Device Slipped 8 8
Sharp Edges 7 7
Device Tipped Over 7 7
Material Split, Cut or Torn 6 6
Component Missing 6 6
Improper or Incorrect Procedure or Method 6 6
Inadequacy of Device Shape and/or Size 6 6
Solder Joint Fracture 5 5
Detachment Of Device Component 5 5
Installation-Related Problem 5 5
Material Twisted/Bent 4 4
Crack 4 4
Loose or Intermittent Connection 4 4
Product Quality Problem 3 3
Entrapment of Device 3 3
Misassembly During Maintenance/Repair 3 3
Device Fell 3 3
Patient-Device Incompatibility 3 3
Protective Measures Problem 3 3
Patient Device Interaction Problem 3 3
Scratched Material 2 2
Compatibility Problem 2 2
Material Deformation 2 2
Fail-Safe Problem 2 2
Human-Device Interface Problem 2 2
Physical Resistance/Sticking 2 2
Misassembly by Users 2 2
Device Handling Problem 2 2
Noise, Audible 2 2
Electromagnetic Interference 2 2
Difficult to Fold, Unfold or Collapse 2 2
Material Fragmentation 2 2
Unintended System Motion 2 2
Material Separation 2 2
Separation Failure 1 1
Defective Device 1 1
Retraction Problem 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Unstable 1 1
Inadequate Instructions for Healthcare Professional 1 1
Misassembled 1 1
Fire 1 1
Degraded 1 1
Disconnection 1 1
Material Disintegration 1 1
Collapse 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
No Apparent Adverse Event 1 1
Unintended Deflation 1 1
Misassembled During Installation 1 1
Unclear Information 1 1
Missing Information 1 1
Inadequate User Interface 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Connection Problem 1 1
Device Operates Differently Than Expected 1 1
Device Unsafe to Use in Environment 1 1
Material Protrusion/Extrusion 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 76 76
Fall 72 72
Insufficient Information 56 56
No Clinical Signs, Symptoms or Conditions 51 51
Laceration(s) 49 49
Head Injury 17 17
Injury 15 15
Bruise/Contusion 13 13
Death 10 10
Limb Fracture 9 9
No Known Impact Or Consequence To Patient 8 8
Abrasion 8 8
Pain 8 8
Hip Fracture 6 6
Brain Injury 5 5
Hematoma 5 5
Fracture, Arm 4 4
Crushing Injury 4 4
Post Traumatic Wound Infection 4 4
Loss of consciousness 4 4
Pressure Sores 4 4
Swelling/ Edema 4 4
Tooth Fracture 3 3
Joint Dislocation 3 3
Damage to Ligament(s) 3 3
Headache 2 2
Burn(s) 2 2
No Consequences Or Impact To Patient 2 2
Spinal Column Injury 2 2
Tissue Damage 2 2
Neck Stiffness 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Easy Bruising 2 2
Unspecified Tissue Injury 2 2
Multiple Fractures 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Hyperextension 1 1
Muscle/Tendon Damage 1 1
Unspecified Musculoskeletal problem 1 1
Spinal Cord Injury 1 1
Neck Pain 1 1
Inadequate Pain Relief 1 1
Obstruction/Occlusion 1 1
Suture Abrasion 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
No Patient Involvement 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
Unspecified Respiratory Problem 1 1
Vertigo 1 1
Weakness 1 1
Concussion 1 1
Swelling 1 1
Hemorrhage/Bleeding 1 1
Intracranial Hemorrhage 1 1
Myalgia 1 1
Hypoesthesia 1 1
Contusion 1 1
Abscess 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Skin Erosion 1 1
Skin Irritation 1 1
Skull Fracture 1 1

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