TPLC - Total Product Life Cycle

• Device: electrode, cutaneous
• Regulation Description: Cutaneous electrode.
• Product Code: GXY
• Regulation Number: 882.1320
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	6
AMBU INTERNATIONAL A/S
	SUBSTANTIALLY EQUIVALENT	2
ASPECT
	SUBSTANTIALLY EQUIVALENT	9
AXELGAARD MFG
	SUBSTANTIALLY EQUIVALENT	6
BIO PROTECH, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIO-DETEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIO-LOGIC SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	2
CONMED
	SUBSTANTIALLY EQUIVALENT	6
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	3
D.O. WEAVER
	SUBSTANTIALLY EQUIVALENT	1
DURDEN ENTERPRISES
	SUBSTANTIALLY EQUIVALENT	1
DYNATRONICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
EMPI
	SUBSTANTIALLY EQUIVALENT	10
ENRAF-NONIUS B.V.
	SUBSTANTIALLY EQUIVALENT	1
EXCEL TECH. LTD.
	SUBSTANTIALLY EQUIVALENT	1
FERRIS MFG. CORP.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	2
INTELLIGENT HEARING SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
KATECHO, INC.
	SUBSTANTIALLY EQUIVALENT	4
MAXXIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICOTEST A/S
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	10
NAIMCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
OMRON HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
OTTO BOCK HEALTHCARE, GMBH
	SUBSTANTIALLY EQUIVALENT	1
PEPIN MFG., INC.
	SUBSTANTIALLY EQUIVALENT	1
PMT CORP.
	SUBSTANTIALLY EQUIVALENT	1
RHYTHMLINK INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
RICH-MAR CORP.
	SUBSTANTIALLY EQUIVALENT	1
RUDOLF STORZ GMBH
	SUBSTANTIALLY EQUIVALENT	1
SELECTIVE MED COMPONENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOMATICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES
	SUBSTANTIALLY EQUIVALENT	1
TECHNOMED EUROPE
	SUBSTANTIALLY EQUIVALENT	2
VALLEYLAB
	SUBSTANTIALLY EQUIVALENT	1
VERMONT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
VISION QUEST INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
W. LORENZ SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
Well-Life Healthcare Limited
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No Known Device Problem	5
Break	1
Chemical reaction	1
Electrode contact(s), problem with	1
Needle, separation	1
Unknown (for use when the device problem is not known)	1
Total Device Problems	10

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Axiobionics, LLC	II	Aug-01-2011
2	Covidien LLC dba Uni-Patch	II	Dec-10-2012
3	NAImco Inc dba Richmar Inc	II	Feb-14-2013
4	Nellcor Puritan Bennett Inc. (dba Covidien LP)	I	Jan-26-2012