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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
Break 41
Mechanical issue 41
Unintended movement 19
No Known Device Problem 19
Device displays error message 14
Fire 14
Sticking 14
Noise, Audible 14
Slippage of device or device component 13
Loss of power 12
Unintended system motion 11
Smoking 10
Device inoperable 10
Use of Device Issue 9
Tipover 9
Failure to shut off 9
No Information 7
Unintended collision 7
Device stops intermittently 7
Bent 6
Self-activation or keying 6
Detachment of device component 6
Failure to align 6
Crack 6
Loose or intermittent connection 6
Malposition of device 5
Component missing 5
Melted 5
No display or display failure 5
Improper or incorrect procedure or method 5
Mechanics altered 4
Device alarm system issue 4
Detachment of device or device component 4
Overheating of device or device component 4
Leak 4
Battery issue 3
Spark 3
No code available 3
Shipping damage or problem 2
Unable to confirm conditions of use 2
Material twisted 2
Fracture 2
Migration of device or device component 2
Product quality issue 2
Unstable 2
Vibration 2
Charging issue 2
Power source issue 2
Electrical shorting 2
Material separation 2
Device emits odor 2
Mechanical jam 2
Torn material 2
Collapse 2
Component falling 2
Entrapment of device or device component 2
Device damaged prior to use 2
Difficult or delayed activation 1
Positioning Issue 1
Insufficient flow or underinfusion 1
Burn of device or device component 1
Nonstandard device or device component 1
Material Protrusion 1
Out-of-box failure 1
Device or device component damaged by another device 1
Failure to power-up 1
Failure to deploy 1
Handpiece detachment 1
Method, improper/incorrect 1
Incorrect device or component shipped 1
Material deformation 1
Arcing 1
Device-device incompatibility 1
Device maintenance issue 1
Peeled 1
Flammable 1
Battery charger, defective 1
Defective component 1
Failure to Adhere or Bond 1
Failure to sense 1
Burst 1
Failure to cycle 1
Measurement system incompatibility 1
Communication or transmission issue 1
Computer system security issue 1
Unknown (for use when the device problem is not known) 1
Connector pin failure 1
Improper gas output 1
Intermittent continuity 1
Electrical issue 1
Device remains activated 1
Inadequate service 1
Cable, defective 1
Total Device Problems 495

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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