ILO — Pack, Hot Or Cold, Water Circulating Class II
FDA product code ILO covers "Pack, Hot Or Cold, Water Circulating", a Class II medical device regulated under 21 CFR 890.5720. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ILO
- Device Class
- Class II
- Regulation Number
- 890.5720
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213097 | pain management technologies | Armory Motion | June 10, 2022 |
| K083008 | elbio co | COOLSKIN | June 10, 2009 |
| K073675 | gaymar industries | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | May 8, 2008 |
| K072152 | juniper medical | JUNIPER CLN1 DERMAL COOLING DEVICE | September 7, 2007 |
| K070402 | breg | MODIFICATION TO POLAR CARE 500 | March 29, 2007 |
| K040317 | mark h. friedman | IVC SYSTEM | May 7, 2004 |
| K973023 | hollister | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET | November 3, 1997 |
| K970197 | adroit medical systems | HTP-1500 LOCALIZED HEAT THERAPY PUMP | September 10, 1997 |
| K964799 | ormed | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY | August 29, 1997 |
| K964354 | ormed | ARTOCOOL-S WATER CIRCULATING COLD PACK | August 29, 1997 |
| K964710 | med technology | BLEDSOE COLD CONTROL | May 9, 1997 |
| K970533 | smith and nephew | MODEL 1100 COLD THERAPY DEVICE | April 15, 1997 |
| K962983 | adroit medical systems | STERILE SOFT-TEMP | January 10, 1997 |
| K964006 | hollister | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) | December 31, 1996 |
| K964057 | hollister | INCARE HOT/ICE SYSTEM SHOULDER BLANKET | December 31, 1996 |
| K963596 | breg | POLAR CARE 300 | December 4, 1996 |
| K962537 | hollister | INCARE HOT/ICE LITE MACHINE | November 27, 1996 |
| K961621 | therapy concepts | THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM | October 31, 1996 |
| K961425 | bio compression systems | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTI | October 28, 1996 |
| K963261 | electro-biology | EBI THERMAL THERAPY SYSTEM | September 27, 1996 |