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TPLC
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show TPLC since
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Device
vehicle, motorized 3-wheeled
Regulation Description
Motorized three-wheeled vehicle.
Product Code
INI
Regulation Number
890.3800
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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