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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
FREEDOM
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
JIANGSU JUMAO MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MOTION COMPOSITES
  SUBSTANTIALLY EQUIVALENT 2
NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROACTIVE COMFORT, LLC
  SUBSTANTIALLY EQUIVALENT 1
R82 A/S
  SUBSTANTIALLY EQUIVALENT 1
RUPIANI
  SUBSTANTIALLY EQUIVALENT 1
WINNER SG PTE LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 276
Bent 82
Unstable 79
Frame 75
Device Operates Differently Than Expected 33
Mechanical Problem 32
Detachment Of Device Component 30
Wheel 30
Crack 27
Out-Of-Box Failure 26
Torn Material 24
Weld 23
Product Quality Problem 23
Adverse Event Without Identified Device or Use Problem 19
Use of Device Problem 13
Device Slipped 12
Unintended Movement 10
Device Inoperable 9
Detachment of Device or device Component 9
Caster 9
Material Frayed 8
Insufficient Information 8
Unraveled Material 7
Component Missing 7
Improper or Incorrect Procedure or Method 7
Device Subassembly 6
Fracture 6
Scratched Material 6
Bolt 6
Material Integrity Problem 5
Wheelchair, Wheels 5
Material Separation 5
Inadequacy of Device Shape and/or Size 5
Mechanics Altered 5
Hole In Material 5
Brake 4
Noise, Audible 4
Naturally Worn 4
Rail 4
Collapse 4
Appropriate Term/Code Not Available 3
Cable 3
Installation-Related Problem 3
Misassembly during Maintenance / Repair 3
Misassembled 2
Tube 2
Device Tipped Over 2
Material Deformation 2
Component Falling 2
Spacer 2
Mechanical Jam 2
Housing 2
Joystick 2
Screw 2
Bearings 2
Lock 2
Positioning Problem 2
Pin 2
Protective Measures Problem 2
Handpiece 2
Material Split, Cut or Torn 2
Sharp Edges 2
Loose or Intermittent Connection 2
Unintended Collision 2
Inadequate or Insufficient Training 2
Solder Joint Fracture 2
Failure to Align 2
Patient-Device Incompatibility 2
Thread 2
Misassembly by Users 1
Unclear Information 1
Device Markings / Labelling Problem 1
Human-Device Interface Problem 1
Ball 1
Device Displays Incorrect Message 1
Structural Problem 1
Device Damaged Prior to Use 1
Defective Component 1
Device Emits Odor 1
Disconnection 1
Material Fragmentation 1
Latch 1
Fire 1
Maintenance Does Not Comply To Manufacturers Recommendations 1
Side Rail 1
Wheelchair, Tires 1
Misassembled During Installation 1
No Apparent Adverse Event 1
Bolus mechanism failure 1
Corroded 1
Device Maintenance Issue 1
Device Misassembled During Manufacturing / Shipping 1
Unintended Ejection 1
Unintended System Motion 1
Smoking 1
Device Contamination with Chemical or Other Material 1
Human Factors Issue 1
Cover 1
Extender 1
Loss of or Failure to Bond 1
Total Device Problems 1045

Recalls
Manufacturer Recall Class Date Posted
1 Karman Healthcare Inc II Feb-27-2016
2 Sunrise Medical (US) LLC II Jul-25-2016
3 Sunrise Medical (US) LLC II Aug-26-2015
4 Sunrise Medical (US) LLC II Jan-27-2015
5 TiSport, Llc II Aug-20-2019

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