Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5720](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5720) → ILO — Pack, Hot Or Cold, Water Circulating # ILO · Pack, Hot Or Cold, Water Circulating _Physical Medicine · 21 CFR 890.5720 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO ## Overview - **Product Code:** ILO - **Device Name:** Pack, Hot Or Cold, Water Circulating - **Regulation:** [21 CFR 890.5720](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5720) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K213097.md) | Armory Motion | Pain Management Technologies, Inc. | Jun 10, 2022 | SESE | | [K083008](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K083008.md) | COOLSKIN | Elbio Co., Ltd. | Jun 10, 2009 | SESE | | [K073675](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K073675.md) | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | Gaymar Industries, Inc. | May 8, 2008 | SESE | | [K072152](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K072152.md) | JUNIPER CLN1 DERMAL COOLING DEVICE | Juniper Medical, Inc. | Sep 7, 2007 | SESE | | [K070402](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K070402.md) | MODIFICATION TO POLAR CARE 500 | Breg, Inc. | Mar 29, 2007 | SESE | | [K040317](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K040317.md) | IVC SYSTEM | Mark H. Friedman | May 7, 2004 | SESE | | [K973023](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K973023.md) | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET | Hollister, Inc. | Nov 3, 1997 | SESE | | [K970197](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K970197.md) | HTP-1500 LOCALIZED HEAT THERAPY PUMP | Adroit Medical Systems, Inc. | Sep 10, 1997 | SESE | | [K964799](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K964799.md) | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY | Ormed GmbH | Aug 29, 1997 | SESE | | [K964354](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K964354.md) | ARTOCOOL-S WATER CIRCULATING COLD PACK | Ormed GmbH | Aug 29, 1997 | SESE | | [K964710](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K964710.md) | BLEDSOE COLD CONTROL | Med Technology, Inc. | May 9, 1997 | SESE | | [K970533](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K970533.md) | MODEL 1100 COLD THERAPY DEVICE | Smith & Nephew, Inc. | Apr 15, 1997 | SESE | | [K962983](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K962983.md) | STERILE SOFT-TEMP | Adroit Medical Systems, Inc. | Jan 10, 1997 | SESE | | [K964057](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K964057.md) | INCARE HOT/ICE SYSTEM SHOULDER BLANKET | Hollister, Inc. | Dec 31, 1996 | SESE | | [K964006](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K964006.md) | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) | Hollister, Inc. | Dec 31, 1996 | SESE | | [K963596](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K963596.md) | POLAR CARE 300 | Breg, Inc. | Dec 4, 1996 | SESE | | [K962537](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K962537.md) | INCARE HOT/ICE LITE MACHINE | Hollister, Inc. | Nov 27, 1996 | SESE | | [K961621](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K961621.md) | THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM | Therapy Concepts, Inc. | Oct 31, 1996 | SESE | | [K961425](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K961425.md) | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS | Bio Compression Systems, Inc. | Oct 28, 1996 | SESE | | [K963261](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K963261.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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