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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 34
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
No code available 143
Break 63
Device operates differently than expected 53
Fracture 50
Mechanical issue 43
No Known Device Problem 41
Unintended movement 38
Fire 30
Detachment of device component 22
Use of Device Issue 18
No Information 15
Noise, Audible 14
Sticking 14
Device displays error message 14
Slippage of device or device component 13
Unintended system motion 12
Loss of power 12
Smoking 10
Device inoperable 10
Device stops intermittently 9
Unintended collision 9
Tipover 9
Failure to shut off 9
Improper or incorrect procedure or method 8
Malposition of device 7
Detachment of device or device component 6
Failure to align 6
Self-activation or keying 6
Loose or intermittent connection 6
Bent 6
Crack 6
No display or display failure 5
Melted 5
Component missing 5
Spark 4
Overheating of device or device component 4
Leak 4
Burn of device or device component 4
Device alarm system issue 4
Mechanical jam 4
Mechanics altered 4
Power source issue 3
Component falling 3
Battery issue 3
Unstable 3
Vibration 2
Material separation 2
Shipping damage or problem 2
Charging issue 2
Unable to confirm conditions of use 2
Device damaged prior to use 2
Electrical issue 2
Entrapment of device or device component 2
Collapse 2
Device emits odor 2
Product quality issue 2
Migration of device or device component 2
Device maintenance issue 2
Electrical shorting 2
Torn material 2
Material twisted 2
Measurement system incompatibility 1
Device or device component damaged by another device 1
Device-device incompatibility 1
Positioning Issue 1
Human-Device Interface Issue 1
Inadequate user interface 1
Incorrect device or component shipped 1
Installation-related problem 1
Maintenance does not comply to manufacturers recommendations 1
Material deformation 1
Material Protrusion 1
Protective measure issue 1
Not Applicable 1
Improper gas output 1
Handpiece detachment 1
Nonstandard device or device component 1
Method, improper/incorrect 1
Device remains activated 1
Failure to power-up 1
Peeled 1
Failure to cycle 1
Failure to deploy 1
Flammable 1
Connector pin failure 1
Intermittent continuity 1
Failure to Adhere or Bond 1
Battery charger, defective 1
Burst 1
Defective component 1
Cable, defective 1
Out-of-box failure 1
Obstruction within device 1
Difficult or delayed activation 1
Arcing 1
Communication or transmission issue 1
Computer system security issue 1
Failure to service 1
Inadequate service 1
Failure to sense 1
Total Device Problems 828

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 2 3 2 1 0 2 1 2 2 0 2
Class III 0 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 Permobil, Ab II Oct-03-2017
12 Pride Mobility Products Corp II Jan-03-2017
13 Pride Mobility Products Corp II Sep-29-2010
14 Pride Mobility Products Corp II Aug-27-2008
15 Sunrise Medical Inc II Sep-23-2008
16 Sunrise Medical Inc II Aug-23-2008
17 Sunrise Medical Inc II Aug-14-2007

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