FDA.reportPublic FDA data

510(k) K083008

Device
COOLSKIN
Applicant
Elbio Co., Ltd.
510(k) number
K083008
Product code
ILO
Decision
Substantially Equivalent (SESE)
Decision date
2009-06-10
Date received
2008-10-08
Regulation
890.5720
Classification name
Pack, Hot Or Cold, Water Circulating
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAY MANSOUR
Address
845 Aronson Lake Ct. Roswell GA US 30075 30075

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ILO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213097Armory MotionPain Management Technologies, Inc.2022-06-10
K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.2008-05-08
K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.2007-09-07
K070402MODIFICATION TO POLAR CARE 500Breg, Inc.2007-03-29
K040317IVC SYSTEMMark H. Friedman2004-05-07
K973023INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKETHollister, Inc.1997-11-03
K970197HTP-1500 LOCALIZED HEAT THERAPY PUMPAdroit Medical Systems, Inc.1997-09-10
K964799ARTROTHERM CRYOTHERAPY AND THERNOTHERAPYOrmed GmbH1997-08-29
K964354ARTOCOOL-S WATER CIRCULATING COLD PACKOrmed GmbH1997-08-29
K964710BLEDSOE COLD CONTROLMed Technology, Inc.1997-05-09
K970533MODEL 1100 COLD THERAPY DEVICESmith & Nephew, Inc.1997-04-15
K962983STERILE SOFT-TEMPAdroit Medical Systems, Inc.1997-01-10
K964057INCARE HOT/ICE SYSTEM SHOULDER BLANKETHollister, Inc.1996-12-31
K964006INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)Hollister, Inc.1996-12-31
K963596POLAR CARE 300Breg, Inc.1996-12-04