TPLC - Total Product Life Cycle

Device	blood pressure cuff
Regulation Description	Blood pressure cuff.
Definition	A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Product Code	DXQ
Regulation Number	870.1120
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	5
ADVANTAGE MEDICAL CABLES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET
	SUBSTANTIALLY EQUIVALENT	2
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARDICARE COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAREMATE MEDICAL DEVICE CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
CAS MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY INTL., LTD.
		1
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL
	SUBSTANTIALLY EQUIVALENT	2
DRAEGER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ETHOX INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	5
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
HEWLETT-PACKARD CO.
	SUBSTANTIALLY EQUIVALENT	3
ICU MEDICAL SALES, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
KOVEN TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDASONICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE
	SUBSTANTIALLY EQUIVALENT	2
M-PACT
	SUBSTANTIALLY EQUIVALENT	1
NIHON SEIMITSU SOKKI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
SUNTECH MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
TRIMLINE MEDICAL PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	2
TYTAN MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
UNIMED
	SUBSTANTIALLY EQUIVALENT	2
VITAL SIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	3
WARNER-LAMBERT CO.
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	4
WENZHOU KINDCARE IMPORT & EXPORT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY
	SUBSTANTIALLY EQUIVALENT	1
YA HORNG ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZEFON INTL.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Material separation	39
Unraveled material	16
Flaked	11
Break	9
Difficult to remove	7
No code available	6
Uncoiled	3
Material fragmentation	3
Peeled	3
Material frayed	2
Occlusion within device	2
Degraded	2
Split	2
Buckled material	1
Detachment of device or device component	1
Device operates differently than expected	1
Difficult to advance	1
Material deformation	1
Material integrity issue	1
Material twisted	1
No Known Device Problem	1
Torn material	1
No Information	1
Fracture	1
Bent	1
Sticking	1
Stretched	1
Total Device Problems	119

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare, LLC	II	Jun-22-2011