BEUDAMED
    Product Code: IRQ FDA class 1 21 CFR 890.5950

    Unit, Heating, Powered

    Physical Medicine

    A powered heating unit is an electrically operated device used to generate and deliver therapeutic heat to body areas, supporting pain relief, muscle relaxation, and improved circulation in physical medicine settings. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IRQ, regulated under 21 CFR 890.5950, within the Physical Medicine medical specialty.

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    510(k)s
    7
    FEI Numbers
    48
    Registration Numbers
    48
    Unique Applicants
    7
    Years Active
    25

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    Basic Information

    Product Code
    IRQ
    Device Class
    FDA class 1
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K050524 EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
    K950350 THEMALATOR. MODELS T-4-S, T-8-S, ETC.
    K924023 FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917
    K880644 ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
    K861340 R1750 AND R1424 POWERED HEATING UNITS
    K832177 PULSAIR MODEL SP-1
    K801625 THERMOLATOR HEATING UNIT

    FEI Numbers

    This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.