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510(k) Data Aggregation

    K Number
    K042145
    Device Name
    READY-HEAT BLANKET
    Manufacturer
    TECHTRADE LLC
    Date Cleared
    2004-09-17

    (39 days)

    Product Code
    KME
    Regulation Number
    880.6060
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Potomac, Maryland 20854-3305

    Re: K042145

    Trade/Device Name: Ready Heat™ Blanket Regulation Number: 880.6060

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To provide warm relief

    Device Description

    Ready Heat™ blanket

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "Ready Heat™ Blanket." It primarily addresses regulatory approval and does not contain specific information about acceptance criteria or a study proving the device meets them.

    Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence to predicate devices, not performance testing details.

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