Vehicle, Motorized 3-wheeled

Device Code: 5113

Product Code(s): INI

Device Classification Information

Device Type ID5113
Device NameVehicle, Motorized 3-wheeled
Regulation DescriptionMotorized Three-wheeled Vehicle.
Regulation Medical SpecialtyPhysical Medicine
Review PanelPhysical Medicine
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(k)
CFR Regulation Number890.3800 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeINI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5113
DeviceVehicle, Motorized 3-wheeled
Product CodeINI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMotorized Three-wheeled Vehicle.
CFR Regulation Number890.3800 [🔎]
Premarket Reviews
ManufacturerDecision
CHIEN TI ENTERPRISE CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
FREERIDER CORP
 
SUBSTANTIALLY EQUIVALENT
 1
HEARTWAY MEDICAL PRODUCTS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 4
KWANG YANG
 
SUBSTANTIALLY EQUIVALENT
 1
KWANG YANG MOTOR CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
MERITS
 
SUBSTANTIALLY EQUIVALENT
 2
MERITS HEALTH PRODUCTS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
MOVING LIFE LTD
 
SUBSTANTIALLY EQUIVALENT
 1
TZORA ACTIVE SYSTEMS LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
Device Problems
Appropriate Term/Code Not Available
 113
Adverse Event Without Identified Device Or Use Problem
 19
Fire
 18
Break
 17
Device Inoperable
 16
Unintended Movement
 14
Product Quality Problem
 12
Device Stops Intermittently
 10
Unstable
 7
Device Tipped Over
 6
Insufficient Information
 5
Crack
 4
Device Operates Differently Than Expected
 4
Bent
 2
No Apparent Adverse Event
 2
Device Displays Incorrect Message
2
Mechanical Problem
 2
Thermal Decomposition Of Device
 2
Component Falling
 2
Detachment Of Device Component
 2
Unintended Collision
 2
Sticking
 1
Alarm Not Visible
1
Material Separation
 1
Environmental Compatibility Problem
 1
Mechanical Jam
 1
Device Damaged Prior To Use
1
Overheating Of Device
 1
Device Slipped
 1
Detachment Of Device Or Device Component
 1
Failure To Shut Off
 1
Naturally Worn
 1
Noise, Audible
 1
Self-Activation Or Keying
1
Inadequate Storage
 1
Melted
 1
Smoking
 1
Use Of Device Problem
 1
Material Disintegration
 1
Fracture
 1
Sparking
 1
Battery Problem
 1
Charging Problem
1
Total Device Problems 283
Recalls
Manufacturer Recall Class Date Posted
1
Golden Technologies, Inc.
 II Mar-20-2014
TPLC Last Update: 2019-04-02 21:00:26
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