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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
AMERICAN BANTEX CORP
  SUBSTANTIALLY EQUIVALENT 2
AMIGO MOBILITY INTL., INC.
  1
  SUBSTANTIALLY EQUIVALENT 5
BESTEAM TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 4
BRUNO INDEPENDENT LIVING AIDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BURKE, INC.
  SUBSTANTIALLY EQUIVALENT 3
COMFORT ORTHOPEDIC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 6
DALTON MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ELECTRIC MOBILITY CORP.
  1
  SUBSTANTIALLY EQUIVALENT 2
EMG
  SUBSTANTIALLY EQUIVALENT 1
EVEREST & JENNINGS, INC.
  SUBSTANTIALLY EQUIVALENT 3
GOLDEN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
HEARTWAY MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 14
HOVEROUND CORP.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
KARMA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KWANG YANG
  SUBSTANTIALLY EQUIVALENT 5
LERADO CHINA LIMITED
  SUBSTANTIALLY EQUIVALENT 5
MEDLINE
  SUBSTANTIALLY EQUIVALENT 9
MERITS
  SUBSTANTIALLY EQUIVALENT 4
PRIDE MOBILITY PRODUCTS CORP.
  6
  SUBSTANTIALLY EQUIVALENT 18
Shanghai Ruike Sports Goods CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHOPRIDER INTL., INC.
  SUBSTANTIALLY EQUIVALENT 3
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WU'S
  SUBSTANTIALLY EQUIVALENT 15

Device Problems
Break 23
Product quality issue 18
Unintended movement 17
Device inoperable 16
No Known Device Problem 12
Device stops intermittently 10
Fire 8
Unstable 7
Tipover 7
Device operates differently than expected 6
Overheating of device or device component 6
No Information 5
Burn of device or device component 4
Detachment of device component 4
Crack 4
No code available 3
Not Applicable 2
Component falling 2
Bent 2
Mechanical issue 2
Unintended collision 2
Device displays error message 2
Spark 1
Unable to confirm conditions of use 1
Battery issue 1
Charging issue 1
Environmental control or utility issue 1
Failure to shut off 1
Mechanical jam 1
Naturally worn 1
Inadequate storage 1
Device damaged prior to use 1
Inaccurate delivery 1
Melted 1
Misapplication 1
Fluid leak 1
Fracture 1
Self-activation or keying 1
Material separation 1
Slippage of device or device component 1
Smoking 1
Sticking 1
Alarm not visible 1
Component(s), broken 1
Corrosion 1
Material disintegration 1
Noise, Audible 1
Total Device Problems 187

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 2 0 0 1 1 2 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Electric Mobility Corp II Nov-18-2010
2 Electric Mobility Corp II Nov-21-2007
3 Electric Mobility Corp II Nov-21-2007
4 Golden Technologies, Inc. II Mar-20-2014
5 Invacare Corporation II Jan-17-2012
6 Pride Mobility Products Corp II Jul-03-2012
7 Pride Mobility Products Corp II Sep-14-2011
8 S.A.E. AFIKIM II Oct-30-2013

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