BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Rachel's Remedy

    K Number: K150139 · Decision May 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    120

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    Basic Information

    Device Name
    Rachel's Remedy
    K Number
    K150139
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5730
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rachel'S Remedies, LLC
    Date Received
    January 22, 2015
    Decision Date
    May 22, 2015
    Product Code
    IMA
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IMA Pack, Heat, Moist

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