TPLC - Total Product Life Cycle

• Device: pack, hot or cold, water circulating
• Regulation Description: Water circulating hot or cold pack.
• Product Code: ILO
• Regulation Number: 890.5720
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADROIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
AIRCAST, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	2
BIO COMPRESSION SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BURKE, INC.
	SUBSTANTIALLY EQUIVALENT	2
ELBIO CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GAYMAR INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	5
HOLLISTER, INC.
	SUBSTANTIALLY EQUIVALENT	6
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
INNOVATION SPORTS, INC.
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
JUNIPER MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
KINETIC CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOFIX
	SUBSTANTIALLY EQUIVALENT	6
SEABROOK MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	6
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPENCO
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1

Device Problems
Smoking	2
No Information	2
Unknown (for use when the device problem is not known)	1
Burn of device or device component	1
Misassembled	1
Pacing inadequately	1
Total Device Problems	8

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Breg Inc	II	Feb-12-2013
2	Breg Inc, An Orthofix Company	II	Sep-04-2009
3	Cincinnati Sub-Zero Products Inc	II	Feb-04-2010
4	Pro Trainers' Choice Company	II	Jun-24-2011