ILO — Pack, Hot Or Cold, Water Circulating Class II
FDA Device Classification
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 |
| K964354 | ormed | ARTOCOOL-S WATER CIRCULATING COLD PACK | August 29, 1997 |
| K964799 | ormed | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY | 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 |