TPLC - Total Product Life Cycle

• Device: wheelchair, mechanical
• Regulation Description: Mechanical wheelchair.
• Product Code: IOR
• Regulation Number: 890.3850
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
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	8
FUTURE MOBILITY HEALTHCARE INC.
	SUBSTANTIALLY EQUIVALENT	4
HEARTWAY MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INVACARE CORP.
	SUBSTANTIALLY EQUIVALENT	26
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	6
PENOX TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRIDE MOBILITY PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	2
R POON
	SUBSTANTIALLY EQUIVALENT	1
R82 A/S
	SUBSTANTIALLY EQUIVALENT	3
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	10
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
Product quality issue	17
Break	12
Component(s), broken	7
No Known Device Problem	6
Detachment of device component	6
Collapse	3
Tipover	3
Fracture	3
Sharp/jagged/rough/etched/scratched	2
Component falling	2
Use of Device Issue	2
Device maintenance issue	2
Unknown (for use when the device problem is not known)	1
Detachment of device or device component	1
Mechanical issue	1
Improper or incorrect procedure or method	1
Normal	1
Solder joint failure	1
Inadequate training	1
Folded	1
Mislabeled	1
Human factors issue	1
Design/structure problem	1
Accessory incompatible	1
Difficult to open or close	1
No Information	1
Structural problem	1
Buckled material	1
Misapplication	1
Positioning Issue	1
Difficult to fold or unfold	1
Folding Issue	1
Total Device Problems	85

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	1	1	1	1	3	2
Class III	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	Feb-04-2013
5	Invacare Corporation	II	Nov-25-2009
6	Medline Industries Inc	II	Aug-19-2008
7	Sunrise Medical Inc	II	Dec-28-2010
8	Sunrise Medical (US) LLC	II	Jul-31-2012
9	Sunrise Medical (US) LLC	II	Feb-24-2012
10	TiSport, Llc	II	Sep-07-2011