TPLC - Total Product Life Cycle

• Device: wheelchair, powered
• Regulation Description: Powered wheelchair.
• Product Code: ITI
• Regulation Number: 890.3860
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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	4
HOVEROUND CORP.
	SUBSTANTIALLY EQUIVALENT	13
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	2
INDEPENDENCE TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	1
INVACARE CORP.
	SUBSTANTIALLY EQUIVALENT	32
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
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
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	6
OTTO BOCK HEALTHCARE, GMBH
	SUBSTANTIALLY EQUIVALENT	4
P&F BROTHER IND.,CORP
	SUBSTANTIALLY EQUIVALENT	2
PERMOBIL, INC.
	SUBSTANTIALLY EQUIVALENT	4
PRIDE MOBILITY PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	7
Shanghai Ruike Sports Goods CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUNRISE MEDICAL
	SUBSTANTIALLY EQUIVALENT	11
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
TEFTEC
	SUBSTANTIALLY EQUIVALENT	8
ULRICH-ALBER GMBH
	SUBSTANTIALLY EQUIVALENT	1
WHEELCHAIRS OF KANSAS
	SUBSTANTIALLY EQUIVALENT	2
WU'S
	SUBSTANTIALLY EQUIVALENT	6

Device Problems
Fire	4
Spark	2
Handpiece detachment	1
Method, improper/incorrect	1
Computer system security issue	1
Unintended movement	1
Battery charger, defective	1
Leak	1
Arcing	1
Device stops intermittently	1
Flammable	1
Component falling	1
Cable, defective	1
No Known Device Problem	1
Connector pin failure	1
Break	1
Torn material	1
Use of Device Issue	1
Smoking	1
Detachment of device or device component	1
Unknown (for use when the device problem is not known)	1
Total Device Problems	25

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	2	3	2	1	0	2	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Invacare Corporation	II	Jun-29-2012
2	Invacare Corporation	II	Mar-12-2012
3	Invacare Corporation	II	Dec-29-2009
4	Invacare Corporation	II	Jan-27-2009
5	Invacare Corporation	II	Jul-04-2007
6	Pride Mobility Products Corp	II	Sep-29-2010
7	Pride Mobility Products Corp	II	Aug-27-2008
8	Sunrise Medical Inc	II	Sep-23-2008
9	Sunrise Medical Inc	II	Aug-23-2008
10	Sunrise Medical Inc	II	Aug-14-2007