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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vehicle, motorized 3-wheeled
Regulation Description Motorized three-wheeled vehicle.
Product CodeINI
Regulation Number 890.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
CHIEN TI ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KWANG YANG
  SUBSTANTIALLY EQUIVALENT 1
KWANG YANG MOTOR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOVING LIFE LTD
  SUBSTANTIALLY EQUIVALENT 1
TZORA ACTIVE SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 2
WU'S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 76 76
2017 45 45
2018 51 51
2019 25 25
2020 26 26
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 149 149
Fire 19 19
Adverse Event Without Identified Device or Use Problem 16 16
Device Tipped Over 11 11
Unintended Movement 6 6
Break 4 4
Component Falling 4 4
Mechanical Problem 4 4
Use of Device Problem 3 3
Device Operates Differently Than Expected 3 3
Thermal Decomposition of Device 3 3
Unintended Collision 3 3
Unintended System Motion 3 3
Detachment Of Device Component 3 3
Device Inoperable 2 2
Device Displays Incorrect Message 2 2
Sparking 2 2
Burst Container or Vessel 2 2
Battery 2 2
Connector 2 2
Brake 2 2
Improper or Incorrect Procedure or Method 2 2
Smoking 2 2
Device Stops Intermittently 1 1
Device Emits Odor 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Structural Problem 1 1
Device Unsafe to Use in Environment 1 1
Electrical Shorting 1 1
Environmental Compatibility Problem 1 1
Extrusion 1 1
Failure to Auto Stop 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Moisture or Humidity Problem 1 1
No Fail-Safe Mechanism 1 1
Controller 1 1
Indicator 1 1
Plug 1 1
Corroded 1 1
Disconnection 1 1
Electrical /Electronic Property Problem 1 1
Fracture 1 1
Loss of Power 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Battery Problem 1 1
Computer Operating System Problem 1 1
Detachment of Device or Device Component 1 1
Battery Charger 1 1
Device Component Or Accessory 1 1
Wheel 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 59 59
No Known Impact Or Consequence To Patient 42 42
Injury 35 35
Bone Fracture(s) 19 19
Fall 19 19
Bruise/Contusion 18 18
Abrasion 14 14
Hip Fracture 11 11
No Information 8 8
Contusion 5 5
Death 5 5
Fracture, Arm 5 5
No Consequences Or Impact To Patient 4 4
Head Injury 4 4
Laceration(s) 3 3
Concussion 3 3
Neck Pain 3 3
Muscle/Tendon Damage 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Damage to Ligament(s) 2 2
Pain 2 2
Complaint, Ill-Defined 1 1
Nerve Damage 1 1
Swelling/ Edema 1 1
Tooth Fracture 1 1
Suture Abrasion 1 1
No Patient Involvement 1 1
Crushing Injury 1 1
Swelling 1 1

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