Wheelchair, Powered

Device Code: 5187

Product Code(s): ITI

Device Classification Information

Device Type ID5187
Device NameWheelchair, Powered
Regulation DescriptionPowered Wheelchair.
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 Number890.3860 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeITI
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 ID5187
DeviceWheelchair, Powered
Product CodeITI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPowered Wheelchair.
CFR Regulation Number890.3860 [🔎]
Premarket Reviews
ManufacturerDecision
AAT ALBER ANTRIEBSTECHNIK GMBHJ
 
SUBSTANTIALLY EQUIVALENT
 1
DANE TECHNOLOGIES
 
SUBSTANTIALLY EQUIVALENT
 1
HEARTWAY MEDICAL PRODUCTS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
INVACARE CORP.
 
SUBSTANTIALLY EQUIVALENT
 3
INVACARE CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 5
LERADO ZHONGSHAN PEACEFUL COVE BUSINESS TRADING CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
LEVO AG
 
SUBSTANTIALLY EQUIVALENT
 1
LIL CRITTER, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MAX MOBILITY, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MOTION CONCEPTS
 
SUBSTANTIALLY EQUIVALENT
 2
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
PERMOBIL AB
 
SUBSTANTIALLY EQUIVALENT
 2
PERMOBIL, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
PIHSIANG MACHINERY MFG. CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SUNRISE MEDICAL (US) LLC
 
SUBSTANTIALLY EQUIVALENT
 2
WHILL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
WU'S
 
SUBSTANTIALLY EQUIVALENT
 1
YAMAHA MOTOR CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Appropriate Term/Code Not Available
 265
Break
 102
Plate
 72
Fracture
 63
Adverse Event Without Identified Device Or Use Problem
 60
Unintended Movement
 57
Device Operates Differently Than Expected
 54
Mechanical Problem
 47
Fire
 43
Joystick
 37
Detachment Of Device Component
 30
Motor
 25
Detachment Of Device Or Device Component
 25
Caster
 21
Use Of Device Problem
 21
Bolt
 20
Insufficient Information
 18
Brake
 15
Frame
 14
Device Displays Incorrect Message
14
Noise, Audible
 14
Device Slipped
 14
Sticking
 14
Unintended Collision
 13
Loss Of Power
 12
Unintended System Motion
 12
Device Tipped Over
 12
Smoking
 11
Improper Or Incorrect Procedure Or Method
 11
Wheel
 11
Device Inoperable
 10
Failure To Shut Off
 9
Hinge
 8
Device Stops Intermittently
 8
Wheelchair, Wheels
 7
Weld
 7
Loose Or Intermittent Connection
 7
Malposition Of Device
7
Hub
 6
Failure To Align
 6
Crack
 6
Self-Activation Or Keying
6
Melted
 6
Bent
 6
Component Missing
5
No Display / Image
 5
Wire
 5
Mount
 5
Thermal Decomposition Of Device
 5
Mechanical Jam
 5
Human Factors Issue
 4
Cylinder
 4
Device Subassembly
 4
Mechanics Altered
 4
Device Alarm System
 4
Overheating Of Device
 4
Battery Charger
 4
Unstable
 4
Actuator
 3
Battery
 3
Power Problem
 3
Battery Problem
 3
Screen
 3
Foot Pedal
 3
Electrical /Electronic Property Problem
 3
Leak / Splash
 3
Material Separation
 3
Positioning Failure
2
Device Emits Odor
 2
Installation-Related Problem
 2
Device Maintenance Issue
 2
Electrical Shorting
 2
Collapse
 2
Gears
 2
Controller
 2
Device Damaged Prior To Use
2
Component Falling
 2
Disconnection
 2
Entrapment Of Device
 2
Belt
 2
Screw
 2
Shipping Damage Or Problem
 2
Maintenance Does Not Comply To Manufacturers Recommendations
 2
Charging Problem
2
Defective Component
 2
Device Fell
 2
Vibration
 2
Product Quality Problem
 2
Material Twisted / Bent
 2
Device Operational Issue
 2
Sparking
 2
Fastener
 2
Migration Or Expulsion Of Device
2
Failure To Sense
1
Cable
 1
Burst Container Or Vessel
1
Failure To Cycle
 1
Communication Or Transmission Problem
 1
Human-Device Interface Problem
 1
Measurement System Incompatibility
 1
Total Device Problems 1374
Recalls
Manufacturer Recall Class Date Posted
1
Invacare Corporation
 II Aug-10-2015
2
Invacare Corporation
 II Feb-20-2015
3
Invacare Corporation
 II Jul-22-2014
4
Motion Concepts
 II Sep-17-2014
5
Permobil, Ab
 II Sep-15-2018
6
Permobil, Ab
 II Oct-03-2017
7
Pride Mobility Products Corp
 II Jan-03-2017
TPLC Last Update: 2019-04-02 21:01:47
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