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 |