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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
No code available 40
Break 23
Product quality issue 18
Unintended movement 17
Device inoperable 16
No Known Device Problem 13
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
Component falling 2
Bent 2
Mechanical issue 2
Unintended collision 2
Device displays error message 2
Not Applicable 2
Noise, Audible 1
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
Total Device Problems 225

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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