← Product Code [ILO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO) · K962537 # INCARE HOT/ICE LITE MACHINE (K962537) _Hollister, Inc. · ILO · Nov 27, 1996 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K962537 ## Device Facts - **Applicant:** Hollister, Inc. - **Product Code:** [ILO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO.md) - **Decision Date:** Nov 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5720 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use The InCare HOT/ICE Lite Machine is intended to provide cold therapy to body surfaces by pumping and circulating chilled water through a plastic bag or plastic blanket that has been secured to the patient’s anatomy. ## Device Story Device provides localized cold therapy; circulates chilled water/alcohol mixture through plastic blanket or bag secured to patient anatomy. Used in institutional or home environments. Solid-state electronics control pump and circulation. Healthcare provider or patient secures blanket; device maintains therapy temperature range (50° to 72° F). Output is cooling of localized skin surface; intended to reduce skin temperature for therapeutic benefit. ## Clinical Evidence Bench testing only. Evaluation of skin cooling ability performed using temperature probe on test subjects' skin surface over a specific period. Results confirmed device efficacy in reducing patient skin temperature. ## Technological Characteristics Solid-state electronics; 120VAC, 136 watts, 50/60Hz power supply. Liquid media: water/alcohol mixture (500 ml capacity). Nominal flow rate: 4 GPH; nominal operating pressure: 3.5 PSI. Therapy temperature range: 50° to 72° F (10° to 22° C). Weight: approx 7.1 lbs. Form factor: portable unit for institutional/home use. ## Regulatory 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. ## 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. ## Predicate Devices - InCare HE500 ([K830757](/device/K830757.md)) - InCare System 3 ([K915196](/device/K915196.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} NOV 27 1996 Hollister Incorporated InCare HOT/ICE Lite Machine K962537 # Safety and Effectiveness Summary ## 1. Submitter's name, Address and Contact Person | Submitter | Contact Person | | --- | --- | | Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 | Joseph S. Tokarz Manager, Regulatory Affairs Phone (847)680-2849 Fax (847)918-3860 | Date Summary Prepared - June 26, 1996 ## 2. Name of Device: InCare HOT/ICE Lite Machine ## 3. Name of Predicate Device(s) a. InCare HE500 (K830757) b. InCare System 3 (K915196) ## 4. Description of Device The InCare HOT/ICE Lite Machine incorporates state of the art technology with solid state electronics. The device is designed to deliver cold therapy to a localized area. This is accomplished by circulating cold water through a plastic blanket or bag that has been secured to the patient’s anatomy. The device is intended to be used in an institution or home environment. ## 5. Statement of Intended Use The InCare HOT/ICE Lite Machine is intended to provide cold therapy to body surfaces by pumping and circulating chilled water through a plastic bag or plastic blanket that has been secured to the patient’s anatomy. ## 6. Statement of Technological Characteristics of the Device On the following page is a comparison of the technical specifications of the InCare HOT/ICE Lite Machine and the predicate devices. {1} Hollister Incorporated InCare HOT/ICE Lite Machine | Features/Specs | Proposed device InCare HOT/ICE Lite | InCare HE500 K830757 | InCare System 3 K915196 | | --- | --- | --- | --- | | Intended to provide cold therapy to body surfaces | Yes | Yes | Yes | | Solution Flow Rates GPH=gallons per hour | 4 GPH (nominal) | 15 GPH (nominal) | 19 GPH (nominal) | | Operating Pressure PSI=pounds per square inch | 3.5 PSI (nominal) | 2.5 PSI (nominal) | 4.8 PSI (nominal) | | Liquid media | Water / Alcohol | Water / Alcohol | Water / Alcohol | | Liquid Capacity | 500 ml = 350 ml Water + 150 ml Alcohol | 500 ml = 350 ml Water + 150 ml Alcohol | 650 ml water/alcohol | | Therapy temperature range | 50° to 72° F 10° to 22° C | 40° to 150° F 4° to 40° C | 40° to 150° F 4° to 40° C | | Weight | approx 7.1 lbs | approx 20 lbs | 32 lbs (approximate) | | Power Supply | 120VAC, 136 watts, 50/60Hz | 115 V, 60 Hz, 3 AMPS | 115 VAC, 60 Hz 3 AMPS | ## 7. Performance Testing The InCare HOT/ICE Lite Machine with a HOT/ICE blanket was evaluated for its ability to cool the test subjects skin as measured by a temperature probe on the skin surface. Skin temperature was recorded over a specific period of time. The results indicated that the InCare HOT/ICE Lite Machine in its ability to reduce patient skin temperature. ## 8. Conclusion The InCare HOT/ICE Lite Machine is substantially equivalent to the predicate devices and is safe and effective for its intended use. 37 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K962537](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILO/K962537) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com