InCare Hot/Ice Lite Machine

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K962537 ↗

FDA Product Code

ILO

Device Class

Class II

Regulation

21 CFR Part 890.5720

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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See all devices from Hollister, Inc. →

• What is the primary purpose of the InCare Hot/Ice Lite Machine in clinical settings?

  The InCare Hot/Ice Lite Machine is designed for cold therapy applications, specifically to deliver controlled temperature therapy by circulating chilled water through disposable plastic bags or pads. This aids in pain management and reducing inflammation, commonly used in physical medicine for treating acute injuries, post-surgical recovery, or chronic pain conditions.

• How is the InCare Hot/Ice Lite Machine intended to be used in terms of disposables and reusability?

  The device is flexible in its use—it can be employed in both single-use and reusable settings, depending on whether disposable accessories (like plastic bags or pads) are used. The machine itself is a reusable unit, while the therapy application components (e.g., bags or pads) are intended for single-use, ensuring hygiene and reducing cross-contamination risks.

• What safety considerations should be kept in mind when using the InCare Hot/Ice Lite Machine?

  The InCare Hot/Ice Lite Machine operates under standard electrical safety conditions, meaning it adheres to typical safety protocols for medical electrical equipment. However, it is not MRI-compatible, so it should not be used in or near MRI environments. Always follow the manufacturer’s storage guidelines for water circulation systems to maintain functionality and prevent contamination.

• Are there different models or sizes available for the InCare Hot/Ice Lite Machine, and how would I determine compatibility?

  The device data lists multiple registration numbers (e.g., 3042254805, 3015252349) associated with the InCare Hot/Ice Lite Machine, which may correspond to variations in accessories or configurations. While the base machine itself is portable and standardized, compatibility depends on the disposable accessories (e.g., bag or pad sizes) used for therapy. Check the manufacturer’s documentation or contact Hollister, Inc. to confirm which accessories align with your specific clinical needs.

• How is the regulatory status of the InCare Hot/Ice Lite Machine defined, and what does this mean for purchasing or clinical use?

  The InCare Hot/Ice Lite Machine holds FDA 510(k) clearance (K962537) as a Class II medical device, classified under the product code ILO for 'Pack, Hot or Cold, Water Circulating.' This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA requirements for safety and effectiveness in its intended use for physical medicine applications. Purchasers or clinicians should ensure compliance with FDA guidelines and manufacturer instructions for proper use.