LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964057
    Device Name
    INCARE HOT/ICE SYSTEM SHOULDER BLANKET
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    1996-12-31

    (83 days)

    Product Code
    ILO
    Regulation Number
    890.5720
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K931843
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InCare HOT/ICE System Shoulder Blanket is intended to provided hot/cold therapy for body surfaces.

    Device Description

    Hollister Incorporated, through its InCare division, currently markets the HOT/ICE System which is intended to provide hot/cold therapy for body surfaces. The HOT/ICE System products operate by pumping heated or chilled water through a plastic blanket.

    The proposed devices consist of a connector/tubing that is an integral part of the plastic blanket where warm or cold water is circulated through and is intended to be used for the delivery of hot or cold therapy to the shoulder surface of the body. Detachable hook and loop securing straps allow for more flexibility in positioning the blanket onto the shoulder.

    The proposed HOT/ICE System Shoulder Blanket can be used with all of the circulating pumps within the InCare HOT/ICE System and is available as a sterile product.

    AI/ML Overview

    The provided text is a 510(k) summary for the InCare HOT/ICE Cold Therapy Shoulder Blanket. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, a standalone study with specific performance metrics, or details about ground truth, training sets, or expert involvement in establishing performance.

    Therefore, I cannot provide the requested information. The document does not describe:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes, data provenance, or details of a test set.
    • Information about experts, adjudication methods, or ground truth establishment.
    • A multi-reader multi-case (MRMC) comparative effectiveness study.
    • A standalone performance study with quantifiable results.
    • Details regarding a training set.

    The 510(k) summary primarily functions by asserting that the new device is "substantially equivalent" to a previously cleared device (the predicate device) based on similar intended use, technological characteristics, and safety (including biocompatibility). It aims to show that the new device doesn't raise new questions of safety or effectiveness.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1