Product code ILO
- Device name
- Pack, Hot Or Cold, Water Circulating
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5720
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213097 | Armory Motion | Pain Management Technologies, Inc. | 2022-06-10 |
| K083008 | COOLSKIN | Elbio Co., Ltd. | 2009-06-10 |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | Gaymar Industries, Inc. | 2008-05-08 |
| K072152 | JUNIPER CLN1 DERMAL COOLING DEVICE | Juniper Medical, Inc. | 2007-09-07 |
| K070402 | MODIFICATION TO POLAR CARE 500 | Breg, Inc. | 2007-03-29 |
| K040317 | IVC SYSTEM | Mark H. Friedman | 2004-05-07 |
| K973023 | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET | Hollister, Inc. | 1997-11-03 |
| K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | Adroit Medical Systems, Inc. | 1997-09-10 |
| K964354 | ARTOCOOL-S WATER CIRCULATING COLD PACK | Ormed GmbH | 1997-08-29 |
| K964799 | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY | Ormed GmbH | 1997-08-29 |
| K964710 | BLEDSOE COLD CONTROL | Med Technology, Inc. | 1997-05-09 |
| K970533 | MODEL 1100 COLD THERAPY DEVICE | Smith & Nephew, Inc. | 1997-04-15 |
| K962983 | STERILE SOFT-TEMP | Adroit Medical Systems, Inc. | 1997-01-10 |
| K964006 | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) | Hollister, Inc. | 1996-12-31 |
| K964057 | INCARE HOT/ICE SYSTEM SHOULDER BLANKET | Hollister, Inc. | 1996-12-31 |
| K963596 | POLAR CARE 300 | Breg, Inc. | 1996-12-04 |
| K962537 | INCARE HOT/ICE LITE MACHINE | Hollister, Inc. | 1996-11-27 |
| K961621 | THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM | Therapy Concepts, Inc. | 1996-10-31 |
| K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS | Bio Compression Systems, Inc. | 1996-10-28 |
| K963261 | EBI THERMAL THERAPY SYSTEM | Electro-Biology, Inc. | 1996-09-27 |
| K961855 | POLAR CARE (MODEL 500/50000) | Breg, Inc. | 1996-08-09 |
| K955529 | CRYTRON SYSTEM | Mark H. Friedman | 1996-06-10 |
| K955326 | SPORTS CONTRAST THERAPY SYSTEM ST 7000 | Burke Neutech, Inc. | 1996-04-10 |
| K955057 | MODEL 1100 COLD THERAPY DEVICE | Smith and Nephew Donjoy, Inc. | 1996-03-08 |
| K954095 | MEDICOOL (MODIFICATON) | Microclimate Systems, Inc. | 1996-03-06 |
| K945853 | THERMOTEK H-300 | Thermotek, Inc. | 1995-10-05 |
| K953532 | EBICE | Electro-Biology, Inc. | 1995-10-04 |
| K950395 | THERMOCOOL SYSTEM | Zimmer, Inc. | 1995-08-18 |
| K950711 | T-350 THERAPEUTIC COOLING MACHINE | Thermotek, Inc. | 1995-07-06 |
| K945468 | T-300 COOLER | Temptek, Inc. | 1995-06-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812120005243 | Game Ready* Full Leg Boot Wrap, Large | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005380 | Game Ready* Hand/Wrist Sleeve | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005373 | Game Ready* Hip/Groin Sleeve, Left | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005366 | Game Ready* Hip/Groin Sleeve, Right | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005359 | Game Ready* C-T Spine Sleeve, Large | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005342 | Game Ready* Back Sleeve | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005335 | Game Ready* Shoulder Sleeve, Large, Left | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005328 | Game Ready* Shoulder Sleeve, Large, Right | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005311 | Game Ready* Shoulder Sleeve, Medium, Left | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005304 | Game Ready* Shoulder Sleeve, Medium, Right | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005298 | Game Ready* Ankle Sleeve, Extra Large | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005281 | Game Ready* Ankle Sleeve, Large | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005274 | Game Ready* Straight Elbow Sleeve | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005267 | Game Ready* Articulated Knee Sleeve | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005250 | Game Ready* Straight Knee Sleeve | Avanos Medical, Inc. | 2026-07-31 |
| 00812120004895 | Game Ready* System | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005236 | Game Ready* Half Leg Boot Wrap | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005229 | Game Ready* Flexed Elbow Wrap | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005212 | Game Ready* Hand/Wrist Wrap | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005205 | Game Ready* Hip/Groin Wrap, Left | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005199 | Game Ready* Hip/Groin Wrap, Right | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005182 | Game Ready* C-T Spine Wrap, Large | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005175 | Game Ready* Back Wrap | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005168 | Game Ready* Shoulder Wrap, Large, Left | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005151 | Game Ready* Shoulder Wrap, Large, Right | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005144 | Game Ready* Shoulder Wrap, Medium, Left | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005137 | Game Ready* Shoulder Wrap, Medium, Right | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005120 | Game Ready* Ankle Wrap, Extra Large | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005113 | Game Ready* Ankle Wrap, Large | Avanos Medical, Inc. | 2026-07-31 |
| 00812120005076 | Game Ready* Full Leg Boot Wrap, Medium | Avanos Medical, Inc. | 2026-07-31 |