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

    MOIST HEAT PACK

    K Number: K803177 · Decision Dec 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    15

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MOIST HEAT PACK
    K Number
    K803177
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5730
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Duro-Med Ind., Inc.
    Date Received
    December 16, 1980
    Decision Date
    December 31, 1980
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IMA), ordered by most recent decision date.

    Rachel's Remedy

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HEAT PACK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    STEAM PAK MOIST HEAT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INSULATED THERMOELASTOMER MITT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    REUSABLE MOIST HEAT PACK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Duro-Med Ind., Inc.

    K Number Device Name
    K823903 RUBBER INFLATABLE RING