FDA 510(k) Applications for Medical Device Product Code "ILO"
(Pack, Hot Or Cold, Water Circulating)

FDA 510(k) Number Applicant Device Name Decision Date
K970197 ADROIT MEDICAL SYSTEMS, INC. HTP-1500 LOCALIZED HEAT THERAPY PUMP 09/10/1997
K962983 ADROIT MEDICAL SYSTEMS, INC. STERILE SOFT-TEMP 01/10/1997
K961425 BIO COMPRESSION SYSTEMS, INC. BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS 10/28/1996
K070402 BREG, INC. MODIFICATION TO POLAR CARE 500 03/29/2007
K961855 BREG, INC. POLAR CARE (MODEL 500/50000) 08/09/1996
K963596 BREG, INC. POLAR CARE 300 12/04/1996
K955326 BURKE NEUTECH, INC. SPORTS CONTRAST THERAPY SYSTEM ST 7000 04/10/1996
K083008 ELBIO CO., LTD COOLSKIN 06/10/2009
K963261 ELECTRO-BIOLOGY, INC. EBI THERMAL THERAPY SYSTEM 09/27/1996
K073675 GAYMAR INDUSTRIES, INC. T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP 05/08/2008
K962537 HOLLISTER, INC. INCARE HOT/ICE LITE MACHINE 11/27/1996
K964006 HOLLISTER, INC. INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) 12/31/1996
K973023 HOLLISTER, INC. INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET 11/03/1997
K964057 HOLLISTER, INC. INCARE HOT/ICE SYSTEM SHOULDER BLANKET 12/31/1996
K072152 JUNIPER MEDICAL INC. JUNIPER CLN1 DERMAL COOLING DEVICE 09/07/2007
K955529 MARK H. FRIEDMAN CRYTRON SYSTEM 06/10/1996
K040317 MARK H. FRIEDMAN IVC SYSTEM 05/07/2004
K964710 MED TECHNOLOGY, INC. BLEDSOE COLD CONTROL 05/09/1997
K954095 MICROCLIMATE SYSTEMS, INC. MEDICOOL (MODIFICATON) 03/06/1996
K964354 ORMED GMBH ARTOCOOL-S WATER CIRCULATING COLD PACK 08/29/1997
K964799 ORMED GMBH ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY 08/29/1997
K213097 Pain Management Technologies, Inc. Armory Motion 06/10/2022
K970533 SMITH & NEPHEW, INC. MODEL 1100 COLD THERAPY DEVICE 04/15/1997
K955057 SMITH AND NEPHEW DONJOY, INC. MODEL 1100 COLD THERAPY DEVICE 03/08/1996
K961621 THERAPY CONCEPTS, INC. THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM 10/31/1996


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