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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wheelchair, mechanical
Regulation Description Mechanical wheelchair.
Product CodeIOR
Regulation Number 890.3850
Device Class 1


Premarket Reviews
ManufacturerDecision
ACCESS POINT
  SUBSTANTIALLY EQUIVALENT 3
AERO INNOVATIVE RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRUNO INDEPENDENT LIVING AIDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOURS 'N MOTION
  SUBSTANTIALLY EQUIVALENT 12
COMFORT ORTHOPEDIC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD
  SUBSTANTIALLY EQUIVALENT 3
DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRIC MOBILITY CORP.
  SUBSTANTIALLY EQUIVALENT 1
EVEREST & JENNINGS, INC.
  SUBSTANTIALLY EQUIVALENT 9
FREEDOM
  SUBSTANTIALLY EQUIVALENT 10
FUTURE MOBILITY HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 5
HEARTWAY MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 27
JAN MAO
  SUBSTANTIALLY EQUIVALENT 3
JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARMA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KI MOBILITY LLC
  SUBSTANTIALLY EQUIVALENT 1
KUSCHALL OF AMERICA
  SUBSTANTIALLY EQUIVALENT 4
LERADO CHINA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
LUMEX
  SUBSTANTIALLY EQUIVALENT 2
MADA EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 2
MARTIN MANUFACTURING CO., LLC
  SUBSTANTIALLY EQUIVALENT 1
MAXHEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDCARE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 4
Next Mobility, LLC
  SUBSTANTIALLY EQUIVALENT 2
NISSIN MEDICAL INDUSTRIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE, GMBH
  SUBSTANTIALLY EQUIVALENT 3
PANTHERA PRODUCTION AB
  SUBSTANTIALLY EQUIVALENT 1
PDG PRODUCT DESIGN GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 7
PENOX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIDE MOBILITY PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 2
R POON
  SUBSTANTIALLY EQUIVALENT 1
R82 A/S
  SUBSTANTIALLY EQUIVALENT 4
REGULATORY INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROGUE WHEELS INC
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI HUBANG MEDICAL APPLIANCES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 11
TAIWAN AN I CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
TEMCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
TISPORT, LLC
  SUBSTANTIALLY EQUIVALENT 2
WELL HOME HEALTH PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
WHEELCHAIRS OF KANSAS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 353
Unstable 125
Bent 97
Product quality issue 59
Detachment of device component 47
Torn material 43
Device operates differently than expected 38
Crack 38
Mechanical issue 33
Out-of-box failure 32
Unintended movement 19
Unraveled material 15
No Known Device Problem 14
Naturally worn 13
Device inoperable 12
Slippage of device or device component 10
Collapse 8
Material frayed 8
Component(s), broken 7
Component missing 7
Scratched material 6
Hole in material 6
Component falling 5
Material separation 5
Mechanical jam 5
Mechanics altered 5
Tipover 5
Buckled material 4
No Information 4
Device damaged prior to use 4
Fracture 4
Noise, Audible 4
Improper or incorrect procedure or method 3
Use of Device Issue 3
Positioning Issue 3
Material integrity issue 3
Detachment of device or device component 3
Sharp/jagged/rough/etched/scratched 2
Traditional use 2
Unable to confirm conditions of use 2
Structural problem 2
Failure to align 2
Material deformation 2
Unintended collision 2
Loose or intermittent connection 2
Device maintenance issue 2
Accessory incompatible 1
Corrosion 1
Bolus mechanism failure 1
Loss of or failure to bond 1
Design/structure problem 1
Disconnection 1
Difficult to fold or unfold 1
Vibration 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Size incorrect for patient 1
Smoking 1
Inadequate training 1
Misapplication 1
Mislabeled 1
Normal 1
Device emits odor 1
Difficult to open or close 1
Foreign material present in device 1
Human-Device Interface Issue 1
Incompatibility problem 1
Protective measure issue 1
No code available 1
Defective item 1
Device displays error message 1
Solder joint failure 1
Folded 1
Folding Issue 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Total Device Problems 1098

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 1 1 1 1 1 3 3 4 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 CHENICA INC. II Feb-13-2013
2 Freedom Designs Inc II Dec-19-2007
3 Gunnell, Inc. II Jan-25-2012
4 Invacare Corporation II Jan-08-2014
5 Invacare Corporation II Feb-04-2013
6 Invacare Corporation II Nov-25-2009
7 Karman Healthcare Inc II Feb-27-2016
8 Medline Industries Inc II Aug-19-2008
9 Pdg Product Design Group Inc II Sep-24-2014
10 Silver Star Brands II Nov-14-2014
11 Snug Seat Inc II Dec-16-2014
12 Sunrise Medical Inc II Dec-28-2010
13 Sunrise Medical (US) LLC II Aug-26-2015
14 Sunrise Medical (US) LLC II Jan-27-2015
15 Sunrise Medical (US) LLC II Dec-05-2013
16 Sunrise Medical (US) LLC II Jul-31-2012
17 Sunrise Medical (US) LLC II Feb-24-2012
18 TiSport, Llc II Sep-07-2011

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