BEUDAMED
    Product Code: RDB FDA not classified

    Electric Blanket

    Unknown

    The Electric Blanket (product code RDB) is a device that utilizes microwave or extremely low frequency (ELF) radiation in an electric blanket for warmth. This product is FDA not classified and is regulated under electronic product radiation control authority rather than the standard medical device classification framework. It is GMP exempt with no associated regulation number, medical specialty, implant flag, or life-sustaining designation.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    RDB
    Device Class
    FDA not classified
    Medical Specialty
    Unknown

    Device Characteristics

    ✓
    GMP Exempt
    —
    Implant
    —
    Life Sustain/Support
    —
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A machine that utilizes microwave or elf radiation in an electric blanket.