FDA Product Code
FDA Product Code ILO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5720
510(k) Clearances — 93 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213097 | Armory Motion | Pain Management Technologies, Inc. | 2022-06-10 | Traditional | PDF ↗ |
| K083008 | COOLSKIN | Elbio Co., Ltd. | 2009-06-10 | Abbreviated | PDF ↗ |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | Gaymar Industries, Inc. | 2008-05-08 | Traditional | PDF ↗ |
| K072152 | JUNIPER CLN1 DERMAL COOLING DEVICE | Juniper Medical, Inc. | 2007-09-07 | Traditional | PDF ↗ |
| K070402 | MODIFICATION TO POLAR CARE 500 | Breg, Inc. | 2007-03-29 | Special | PDF ↗ |
| K040317 | IVC SYSTEM | Mark H. Friedman | 2004-05-07 | Traditional | PDF ↗ |
| K973023 | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET | Hollister, Inc. | 1997-11-03 | Traditional | PDF ↗ |
| K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | Adroit Medical Systems, Inc. | 1997-09-10 | Traditional | PDF ↗ |
| K964799 | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY | Ormed GmbH | 1997-08-29 | Traditional | PDF ↗ |
| K964354 | ARTOCOOL-S WATER CIRCULATING COLD PACK | Ormed GmbH | 1997-08-29 | Traditional | PDF ↗ |
| K964710 | BLEDSOE COLD CONTROL | Med Technology, Inc. | 1997-05-09 | Traditional | PDF ↗ |
| K970533 | MODEL 1100 COLD THERAPY DEVICE | Smith & Nephew, Inc. | 1997-04-15 | Traditional | PDF ↗ |
| K962983 | STERILE SOFT-TEMP | Adroit Medical Systems, Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K964057 | INCARE HOT/ICE SYSTEM SHOULDER BLANKET | Hollister, Inc. | 1996-12-31 | Traditional | PDF ↗ |
| K964006 | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) | Hollister, Inc. | 1996-12-31 | Traditional | PDF ↗ |
| K963596 | POLAR CARE 300 | Breg, Inc. | 1996-12-04 | Traditional | PDF ↗ |
| K962537 | INCARE HOT/ICE LITE MACHINE | Hollister, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K961621 | THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM | Therapy Concepts, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS | Bio Compression Systems, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K963261 | EBI THERMAL THERAPY SYSTEM | Electro-Biology, Inc. | 1996-09-27 | Traditional | PDF ↗ |
| K961855 | POLAR CARE (MODEL 500/50000) | Breg, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K955529 | CRYTRON SYSTEM | Mark H. Friedman | 1996-06-10 | Traditional | PDF ↗ |
| K955326 | SPORTS CONTRAST THERAPY SYSTEM ST 7000 | Burke Neutech, Inc. | 1996-04-10 | Traditional | PDF ↗ |
| K955057 | MODEL 1100 COLD THERAPY DEVICE | Smith and Nephew Donjoy, Inc. | 1996-03-08 | Traditional | PDF ↗ |
| K954095 | MEDICOOL (MODIFICATON) | Microclimate Systems, Inc. | 1996-03-06 | Traditional | PDF ↗ |
| K945853 | THERMOTEK H-300 | Thermotek, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K953532 | EBICE | Electro-Biology, Inc. | 1995-10-04 | Traditional | PDF ↗ |
| K950395 | THERMOCOOL SYSTEM | Zimmer, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K950711 | T-350 THERAPEUTIC COOLING MACHINE | Thermotek, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K945468 | T-300 COOLER | Temptek, Inc. | 1995-06-19 | Traditional | PDF ↗ |
| K943497 | CONTRAST 7000 THERAPY SYSTEM | Burke Neutech, Inc. | 1995-06-07 | Traditional | PDF ↗ |
| K945467 | BABYTHERM 8000 WB | Drager, Inc. | 1995-04-28 | Traditional | PDF ↗ |
| K934262 | HPRH HOSPITAL PATIENT RADIANT HEATER | Marley Electric Heating Co. | 1995-04-18 | Traditional | PDF ↗ |
| K945399 | DELTA THERM COLD THERAPY SYSTEM | Deltatherm | 1995-03-07 | Traditional | PDF ↗ |
| K943844 | TOTALLY COOL(TM) TC-1 | Electro Science Technologies, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K944447 | COOL/HEAT THERAPY APPLICATOR | Medical Science Technology, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K945067 | EBICE | Electro-Biology, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K942882 | TOTALLY COOL(TM) TC-2 | Electro Science Technologies, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K944971 | INCARE HOT/ICE COLD THERAPY COOLER | Hollister, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K935841 | DR KOOL | Toronto Medical Corp. | 1994-08-29 | Traditional | PDF ↗ |
| K936143 | ISOCOMFORTER | Isocomforter, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K940429 | ORTHO TECH CRYOLOGIC SYSTEM | Orthopedic Technology, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K940858 | THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) | Innovation Sports, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K940160 | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM | Burke Neutech, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K930918 | HYDROT | Sanker Intl., Inc. | 1994-05-25 | Traditional | PDF ↗ |
| K931203 | COOL-AID | Seabrook Medical Systems, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K931843 | HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS | Hollister, Inc. | 1994-02-02 | Traditional | PDF ↗ |
| K930634 | SUR FLO THERMAL THERAPY PADS | Buckman Co., Inc. | 1993-11-01 | Traditional | PDF ↗ |
| K926151 | LSI6000 THERMAL THERAPY SYSTEM | Burke Neutech, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K925677 | AUTOCHILL ACCESSORY KIT | Aircast, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K923643 | MEDICOOL | Micromedic Systems | 1993-03-31 | Traditional | PDF ↗ |
| K921540 | COOLING/HEATING THERAPY DEVICE | Tempacure Home Care | 1992-07-21 | Traditional | PDF ↗ |
| K920581 | POLAR PAD (STERILE) | Breg, Inc. | 1992-03-20 | Traditional | PDF ↗ |
| K915196 | INCARE HOT/ICE SYSTEM 3 | Hollister, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K913026 | TTU-100THERMAL THERAPY UNIT | Danninger Medical Technology, Inc. | 1991-12-13 | Traditional | PDF ↗ |
| K914434 | POLAR PADS | Breg, Inc. | 1991-10-24 | Traditional | PDF ↗ |
| K913729 | POLAR PUMP, MODEL 500 | Breg, Inc. | 1991-10-18 | Traditional | PDF ↗ |
| K914182 | GOLDEN THERMAL(R) | Seabrook Medical Systems, Inc. | 1991-10-18 | Traditional | PDF ↗ |
| K912722 | HYPER-K HEAT SYSTEM | Baxter Healthcare Corp | 1991-09-11 | Traditional | PDF ↗ |
| K911943 | CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM | Burke, Inc. | 1991-07-19 | Traditional | PDF ↗ |
| K910061 | K-MODULE II HEAT THERAPY SYSTEM | Baxter Healthcare Corp | 1991-02-13 | Traditional | PDF ↗ |
| K904998 | THE BODY COOLER SYSTEM | Costa / French | 1991-01-14 | Traditional | PDF ↗ |
| K902268 | PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM. | Seabrook Medical Systems, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K902269 | ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY | Seabrook Medical Systems, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K900356 | THERMOAIRE SPLINT (TM) (TAS) | Life Enhancement Technologies, LLC | 1990-05-07 | Traditional | PDF ↗ |
| K891091 | TEMPTEK T-1000 THERAPEUTIC COOLING UNIT | Temptek, Inc. | 1990-03-26 | Traditional | PDF ↗ |
| K900355 | MARK VII THERMOREGULATION ASSIST SYSTEM | Life Enhancement Technologies, LLC | 1990-02-15 | Traditional | PDF ↗ |
| K891603 | BODY COOLER OR COOLVEST OR ALPHA BODY COOLER | Alpha Rehabilitation Products | 1989-07-25 | Traditional | PDF ↗ |
| K893706 | COLD/HOT FLUID RADIATION PAD NEUTECH | Burke, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K891092 | TEMPTEK 5010 THERMAL COOLING BLANKET | Temptek, Inc. | 1989-05-26 | Traditional | PDF ↗ |
| K890852 | AQUA-BLANKET HYPER/HYPOHERMIA BLANKET | Ati | 1989-04-14 | Traditional | PDF ↗ |
| K890853 | AQUA-PAD FOR MOIST OR DRY HEAT THERAPY | Ati | 1989-04-14 | Traditional | PDF ↗ |
| K891151 | COOL 'N HEAT MACHINE | Kinetic Concepts, Inc. | 1989-04-06 | Traditional | PDF ↗ |
| K891152 | GRAND COOLING MACHINE | Kinetic Concepts, Inc. | 1989-03-23 | Traditional | PDF ↗ |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | Concept, Inc. | 1988-11-08 | Traditional | PDF ↗ |
| K883681 | DAS SPORT PUMP(TM) | D.A. Schulman, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K882310 | DUAL-TEMP(TM) COOLING/WARMING UNIT | Seabrook Medical Systems, Inc. | 1988-09-23 | Traditional | PDF ↗ |
| K871963 | HOT/ICE DISPOSABLE BLANKET | Thermo Temp, Inc. | 1987-06-26 | Traditional | PDF ↗ |
| K871962 | HOT/ICE DUAL FUNCTION EQUIPMENT | Thermo Temp, Inc. | 1987-06-26 | Traditional | PDF ↗ |
| K852495 | CAST-TECH CO. COOLING SYSTEM | Cast-Tech Co. | 1985-09-05 | Traditional | PDF ↗ |
| K843146 | MICRO-TEMP PUMPS & MICRO-TEMP PADS | Seabrook Medical Systems, Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K833564 | HOT/ICE DISPOSABLE BLANKET | Thermo Temp, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K832819 | MUL-T-PAD | Gaymar Industries, Inc. | 1983-09-26 | Traditional | PDF ↗ |
| K832820 | MUL-T-BLANKET | Gaymar Industries, Inc. | 1983-09-26 | Traditional | PDF ↗ |
| K830757 | HOT/ICE | Thermo Temp, Inc. | 1983-03-29 | Traditional | PDF ↗ |
| K801301 | GOLDEN THERMAL RHINOPLASTY CAST BANDAGE | Auric, Inc. | 1980-06-20 | Traditional | PDF ↗ |
| K791162 | GELSKIN | Spenco Medical Corp. | 1979-09-04 | Traditional | PDF ↗ |
| K780452 | THERA-PAK | Hydro-Med Products, Inc. | 1978-06-21 | Traditional | PDF ↗ |
| K761254 | BAND-AGE ICE-BANDAGE | Surgicot, Inc. | 1977-02-24 | Traditional | PDF ↗ |
| K760910 | DISPOSABLE K-PADS | Gorman Rupp Industries | 1976-12-16 | Traditional | PDF ↗ |
| K760782 | TECNOL PATIENT USE ICE PACK | Tecnol New Jersey Wound Care, Inc. | 1976-12-02 | Traditional | PDF ↗ |
| K760804 | T-PUMP, TEMPERATURE - THERAPY PUMP | Gaymar Industries, Inc. | 1976-10-15 | Traditional | PDF ↗ |
| K760527 | T-PAD | Gaymar Industries, Inc. | 1976-09-03 | Traditional | PDF ↗ |
Product code ILO · Class II · Physical Medicine. Data: openFDA.