Panels › Physical Medicine › Product code ILO · Class 2
Pack, Hot Or Cold, Water Circulating
Regulation 890.5720
0510(k)s in 12 months (93 all time)
4recalls in 12 months (22 all time)
4recalls that name a 510(k)
Top companies in ILO
| Company | 510(k)s | Recalls |
|---|---|---|
| Breg, Inc. | 6 | 2 |
| Hollister, Inc. | 7 | 0 |
| DeRoyal Industries Inc | 0 | 6 |
| Seabrook Medical Systems, Inc. | 6 | 0 |
| Gaymar Industries, Inc. | 5 | 0 |
| Burke Neutech, Inc. | 4 | 0 |
| Cincinnati Sub-Zero Products Inc | 0 | 4 |
| DJO, LLC | 0 | 4 |
| Thermo Temp, Inc. | 4 | 0 |
| Electro-Biology, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2022 | K213097 | Armory Motion Pain Management Technologies, Inc. | ILO |
| Jun 10, 2009 | K083008 | COOLSKIN Elbio Co., Ltd. | ILO |
| May 8, 2008 | K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP Gaymar Industries, Inc. | ILO |
| Sep 7, 2007 | K072152 | JUNIPER CLN1 DERMAL COOLING DEVICE Juniper Medical, Inc. | ILO |
| Mar 29, 2007 | K070402 | MODIFICATION TO POLAR CARE 500 Breg, Inc. | ILO |
| May 7, 2004 | K040317 | IVC SYSTEM Mark H. Friedman | ILO |
| Nov 3, 1997 | K973023 | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET Hollister, Inc. | ILO |
| Sep 10, 1997 | K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP Adroit Medical Systems, Inc. | ILO |
| Aug 29, 1997 | K964799 | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY Ormed GmbH | ILO |
| Aug 29, 1997 | K964354 | ARTOCOOL-S WATER CIRCULATING COLD PACK Ormed GmbH | ILO |
| May 9, 1997 | K964710 | BLEDSOE COLD CONTROL Med Technology, Inc. | ILO |
| Apr 15, 1997 | K970533 | MODEL 1100 COLD THERAPY DEVICE Smith & Nephew, Inc. | ILO |
| Jan 10, 1997 | K962983 | STERILE SOFT-TEMP Adroit Medical Systems, Inc. | ILO |
| Dec 31, 1996 | K964057 | INCARE HOT/ICE SYSTEM SHOULDER BLANKET Hollister, Inc. | ILO |
| Dec 31, 1996 | K964006 | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) Hollister, Inc. | ILO |
| Dec 4, 1996 | K963596 | POLAR CARE 300 Breg, Inc. | ILO |
| Nov 27, 1996 | K962537 | INCARE HOT/ICE LITE MACHINE Hollister, Inc. | ILO |
| Oct 31, 1996 | K961621 | THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM Therapy Concepts, Inc. | ILO |
| Oct 28, 1996 | K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS Bio Compression Systems, Inc. | ILO |
| Sep 27, 1996 | K963261 | EBI THERMAL THERAPY SYSTEM Electro-Biology, Inc. | ILO |
| Aug 9, 1996 | K961855 | POLAR CARE (MODEL 500/50000) Breg, Inc. | ILO |
| Jun 10, 1996 | K955529 | CRYTRON SYSTEM Mark H. Friedman | ILO |
| Apr 10, 1996 | K955326 | SPORTS CONTRAST THERAPY SYSTEM ST 7000 Burke Neutech, Inc. | ILO |
| Mar 8, 1996 | K955057 | MODEL 1100 COLD THERAPY DEVICE Smith and Nephew Donjoy, Inc. | ILO |
| Mar 6, 1996 | K954095 | MEDICOOL (MODIFICATON) Microclimate Systems, Inc. | ILO |
| Oct 5, 1995 | K945853 | THERMOTEK H-300 Thermotek, Inc. | ILO |
| Oct 4, 1995 | K953532 | EBICE Electro-Biology, Inc. | ILO |
| Aug 18, 1995 | K950395 | THERMOCOOL SYSTEM Zimmer, Inc. | ILO |
| Jul 6, 1995 | K950711 | T-350 THERAPEUTIC COOLING MACHINE Thermotek, Inc. | ILO |
| Jun 19, 1995 | K945468 | T-300 COOLER Temptek, Inc. | ILO |
| Jun 7, 1995 | K943497 | CONTRAST 7000 THERAPY SYSTEM Burke Neutech, Inc. | ILO |
| Apr 28, 1995 | K945467 | BABYTHERM 8000 WB Drager, Inc. | ILO |
| Apr 18, 1995 | K934262 | HPRH HOSPITAL PATIENT RADIANT HEATER Marley Electric Heating Co. | ILO |
| Mar 7, 1995 | K945399 | DELTA THERM COLD THERAPY SYSTEM Deltatherm | ILO |
| Feb 9, 1995 | K945067 | EBICE Electro-Biology, Inc. | ILO |
| Feb 9, 1995 | K944447 | COOL/HEAT THERAPY APPLICATOR Medical Science Technology, Inc. | ILO |
| Feb 9, 1995 | K943844 | TOTALLY COOL(TM) TC-1 Electro Science Technologies, Inc. | ILO |
| Feb 9, 1995 | K942882 | TOTALLY COOL(TM) TC-2 Electro Science Technologies, Inc. | ILO |
| Jan 30, 1995 | K944971 | INCARE HOT/ICE COLD THERAPY COOLER Hollister, Inc. | ILO |
| Aug 29, 1994 | K935841 | DR KOOL Toronto Medical Corp., CA | ILO |
| Jul 12, 1994 | K940858 | THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) Innovation Sports, Inc. | ILO |
| Jul 12, 1994 | K940429 | ORTHO TECH CRYOLOGIC SYSTEM Orthopedic Technology, Inc. | ILO |
| Jul 12, 1994 | K936143 | ISOCOMFORTER Isocomforter, Inc. | ILO |
| May 27, 1994 | K940160 | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM Burke Neutech, Inc. | ILO |
| May 25, 1994 | K930918 | HYDROT Sanker Intl., Inc. | ILO |
| Feb 22, 1994 | K931203 | COOL-AID Seabrook Medical Systems, Inc. | ILO |
| Feb 2, 1994 | K931843 | HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS Hollister, Inc. | ILO |
| Nov 1, 1993 | K930634 | SUR FLO THERMAL THERAPY PADS Buckman Co., Inc. | ILO |
| May 26, 1993 | K926151 | LSI6000 THERMAL THERAPY SYSTEM Burke Neutech, Inc. | ILO |
| Apr 14, 1993 | K925677 | AUTOCHILL ACCESSORY KIT Aircast, Inc. | ILO |
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