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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wheelchair, powered
Regulation Description Powered wheelchair.
Product CodeITI
Regulation Number 890.3860
Device Class 2


Premarket Reviews
ManufacturerDecision
21ST CENTURY SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN BANTEX CORP
  SUBSTANTIALLY EQUIVALENT 1
AMIGO MOBILITY INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
BRUNO INDEPENDENT LIVING AIDS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BURKE, INC.
  SUBSTANTIALLY EQUIVALENT 2
COMFORT ORTHOPEDIC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
DALTON MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 5
DANE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
E1 ENT., INC.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRIC MOBILITY CORP.
  SUBSTANTIALLY EQUIVALENT 3
EMG
  SUBSTANTIALLY EQUIVALENT 3
EVEREST & JENNINGS, INC.
  SUBSTANTIALLY EQUIVALENT 17
FORYOU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FREEDOM
  SUBSTANTIALLY EQUIVALENT 2
GENDRON, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOLDEN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEARTWAY MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
HOVEROUND CORP.
  2
  SUBSTANTIALLY EQUIVALENT 13
INDEPENDENCE TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  1
  SUBSTANTIALLY EQUIVALENT 33
JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARMA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
KWANG YANG
  SUBSTANTIALLY EQUIVALENT 1
LERADO CHINA LIMITED
  SUBSTANTIALLY EQUIVALENT 2
LEVO AG
  SUBSTANTIALLY EQUIVALENT 1
LINE IND.(SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERITS
  SUBSTANTIALLY EQUIVALENT 2
MOBILIFE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MOTION CONCEPTS
  SUBSTANTIALLY EQUIVALENT 7
OTTO BOCK HEALTHCARE, GMBH
  SUBSTANTIALLY EQUIVALENT 4
P&F BROTHER IND.,CORP
  SUBSTANTIALLY EQUIVALENT 2
PERMOBIL, INC.
  SUBSTANTIALLY EQUIVALENT 6
PRIDE MOBILITY PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 7
Shanghai Ruike Sports Goods CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  1
  SUBSTANTIALLY EQUIVALENT 11
TEFTEC
  SUBSTANTIALLY EQUIVALENT 8
ULRICH-ALBER GMBH
  SUBSTANTIALLY EQUIVALENT 1
WHEELCHAIRS OF KANSAS
  SUBSTANTIALLY EQUIVALENT 2
WU'S
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Device operates differently than expected 51
No code available 43
Break 43
Mechanical issue 41
No Known Device Problem 25
Unintended movement 20
Fire 15
Sticking 14
Device displays error message 14
Noise, Audible 14
Slippage of device or device component 13
Loss of power 12
Unintended system motion 11
Use of Device Issue 11
Device inoperable 10
Smoking 10
Tipover 9
Unintended collision 9
Failure to shut off 9
No Information 7
Detachment of device component 7
Device stops intermittently 7
Improper or incorrect procedure or method 6
Self-activation or keying 6
Failure to align 6
Bent 6
Crack 6
Loose or intermittent connection 6
Melted 5
No display or display failure 5
Component missing 5
Malposition of device 5
Device alarm system issue 4
Leak 4
Overheating of device or device component 4
Detachment of device or device component 4
Mechanics altered 4
Component falling 3
Spark 3
Battery issue 3
Charging issue 2
Unable to confirm conditions of use 2
Device damaged prior to use 2
Shipping damage or problem 2
Product quality issue 2
Material separation 2
Vibration 2
Unstable 2
Burn of device or device component 2
Collapse 2
Device emits odor 2
Migration of device or device component 2
Entrapment of device or device component 2
Fracture 2
Mechanical jam 2
Material twisted 2
Power source issue 2
Torn material 2
Electrical shorting 2
Device or device component damaged by another device 1
Device-device incompatibility 1
Incorrect device or component shipped 1
Material deformation 1
Material Protrusion 1
Positioning Issue 1
Measurement system incompatibility 1
Not Applicable 1
Improper gas output 1
Handpiece detachment 1
Method, improper/incorrect 1
Device maintenance issue 1
Nonstandard device or device component 1
Peeled 1
Failure to power-up 1
Failure to cycle 1
Failure to deploy 1
Electrical issue 1
Flammable 1
Burst 1
Failure to Adhere or Bond 1
Battery charger, defective 1
Connector pin failure 1
Intermittent continuity 1
Insufficient flow or underinfusion 1
Unknown (for use when the device problem is not known) 1
Failure to service 1
Inadequate service 1
Device remains activated 1
Failure to sense 1
Difficult or delayed activation 1
Arcing 1
Defective component 1
Cable, defective 1
Out-of-box failure 1
Communication or transmission issue 1
Computer system security issue 1
Total Device Problems 555

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 3 2 1 0 2 1 2 2 0
Class III 0 0 0 0 0 0 0 0 0 0

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 Invacare Corporation II Sep-23-2013
5 Invacare Corporation II Jun-29-2012
6 Invacare Corporation II Mar-12-2012
7 Invacare Corporation II Dec-29-2009
8 Invacare Corporation II Jan-27-2009
9 Invacare Corporation II Jul-04-2007
10 Motion Concepts II Sep-17-2014
11 Pride Mobility Products Corp II Sep-29-2010
12 Pride Mobility Products Corp II Aug-27-2008
13 Sunrise Medical Inc II Sep-23-2008
14 Sunrise Medical Inc II Aug-23-2008
15 Sunrise Medical Inc II Aug-14-2007

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