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

    HOT OR COLD PACK (THERMIPAQ)

    K Number: K921446 · Decision Jul 13, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    467
    Registration Numbers
    468
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    108

    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
    HOT OR COLD PACK (THERMIPAQ)
    K Number
    K921446
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5700
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermionics Corp.
    Date Received
    March 27, 1992
    Decision Date
    July 13, 1992
    Product Code
    IME
    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
    IME Pack, Hot Or Cold, Reusable

    Similar 510(k) Clearances

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

    COLD PACK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HOTPAD

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SUBOCCIPITAL ICE PILLOW

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    RE-HEATER, HOT PACK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NICE PACK

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