ILO · Pack, Hot Or Cold, Water Circulating
Physical Medicine · 21 CFR 890.5720 · Class 2
Overview
| Product Code | ILO |
|---|---|
| Device Name | Pack, Hot Or Cold, Water Circulating |
| Regulation | 21 CFR 890.5720 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (20 of 93)
Showing 20 most recent of 93 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213097 | Armory Motion | Pain Management Technologies, Inc. | Jun 10, 2022 | SESE |
| K083008 | COOLSKIN | Elbio Co., Ltd. | Jun 10, 2009 | SESE |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | Gaymar Industries, Inc. | May 8, 2008 | SESE |
| K072152 | JUNIPER CLN1 DERMAL COOLING DEVICE | Juniper Medical, Inc. | Sep 7, 2007 | SESE |
| K070402 | MODIFICATION TO POLAR CARE 500 | Breg, Inc. | Mar 29, 2007 | SESE |
| K040317 | IVC SYSTEM | Mark H. Friedman | May 7, 2004 | SESE |
| K973023 | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET | Hollister, Inc. | Nov 3, 1997 | SESE |
| K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | Adroit Medical Systems, Inc. | Sep 10, 1997 | SESE |
| K964799 | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY | Ormed GmbH | Aug 29, 1997 | SESE |
| K964354 | ARTOCOOL-S WATER CIRCULATING COLD PACK | Ormed GmbH | Aug 29, 1997 | SESE |
| K964710 | BLEDSOE COLD CONTROL | Med Technology, Inc. | May 9, 1997 | SESE |
| K970533 | MODEL 1100 COLD THERAPY DEVICE | Smith & Nephew, Inc. | Apr 15, 1997 | SESE |
| K962983 | STERILE SOFT-TEMP | Adroit Medical Systems, Inc. | Jan 10, 1997 | SESE |
| K964057 | INCARE HOT/ICE SYSTEM SHOULDER BLANKET | Hollister, Inc. | Dec 31, 1996 | SESE |
| K964006 | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) | Hollister, Inc. | Dec 31, 1996 | SESE |
| K963596 | POLAR CARE 300 | Breg, Inc. | Dec 4, 1996 | SESE |
| K962537 | INCARE HOT/ICE LITE MACHINE | Hollister, Inc. | Nov 27, 1996 | SESE |
| K961621 | THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM | Therapy Concepts, Inc. | Oct 31, 1996 | SESE |
| K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS | Bio Compression Systems, Inc. | Oct 28, 1996 | SESE |
| K963261 | EBI THERMAL THERAPY SYSTEM | Electro-Biology, Inc. | Sep 27, 1996 | SESE |
Top Applicants
- Hollister, Inc. — 7 clearances
- Breg, Inc. — 6 clearances
- Seabrook Medical Systems, Inc. — 6 clearances
- Gaymar Industries, Inc. — 5 clearances
- Burke Neutech, Inc. — 4 clearances
