TPLC - Total Product Life Cycle

• Device: stimulator, nerve, transcutaneous, for pain relief
• Regulation Description: Transcutaneous electrical nerve stimulator for pain relief.
• Product Code: GZJ
• Regulation Number: 882.5890
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	2
AVAZZIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
AXELGAARD MFG
	SUBSTANTIALLY EQUIVALENT	1
BIO PROTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMEDICAL ENTERPRISES
	SUBSTANTIALLY EQUIVALENT	20
BIO-RESEARCH ASSOCIATES, INC.
	SUBSTANTIALLY EQUIVALENT	2
CHATTANOOGA GROUP
	SUBSTANTIALLY EQUIVALENT	5
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	4
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	1
DOW
	SUBSTANTIALLY EQUIVALENT	1
DYNATRONICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
ELECTRONIC WAVEFORM LABORATORY, INC.
	SUBSTANTIALLY EQUIVALENT	1
EMPI
	SUBSTANTIALLY EQUIVALENT	17
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FUJI
	SUBSTANTIALLY EQUIVALENT	4
HELIO MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HENLEY
	SUBSTANTIALLY EQUIVALENT	1
INTELSOURCE GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERMEDICS
	SUBSTANTIALLY EQUIVALENT	3
KATECHO, INC.
	SUBSTANTIALLY EQUIVALENT	3
KOALATY PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL RESEARCH LAB., INC.
	SUBSTANTIALLY EQUIVALENT	1
MED-LECTRIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	10
MENTOR CORP.
	SUBSTANTIALLY EQUIVALENT	2
METRON MEDICAL AUSTRALIA PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
METTLER ELECTRONICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
PEPIN MFG., INC.
	SUBSTANTIALLY EQUIVALENT	1
REHABILICARE SYSTEMS
	SUBSTANTIALLY EQUIVALENT	3
RICH-MAR CORP.
	SUBSTANTIALLY EQUIVALENT	2
SELECTIVE MED COMPONENTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHIAN JA MEEI ENTERPRISE
	SUBSTANTIALLY EQUIVALENT	2
SPEMBLY CRYOSURGERY
	SUBSTANTIALLY EQUIVALENT	3
TRI W-G, INC.
	SUBSTANTIALLY EQUIVALENT	1
TUNG FU ELECTRIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VISION QUEST INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
W. LORENZ SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
Well-Life Healthcare Limited
	SUBSTANTIALLY EQUIVALENT	2
XANACARE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Burn of device or device component	1
No Known Device Problem	1
Total Device Problems	2

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Avazzia, Inc	III	Sep-01-2007
2	Neuro Resource Group Inc	II	Apr-28-2011
3	Synaptic Corp	II	Apr-19-2012