BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BODY COOLER OR COOLVEST OR ALPHA BODY COOLER

    K Number: K891603 · Decision Jul 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    1
    Review Days
    127

    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
    BODY COOLER OR COOLVEST OR ALPHA BODY COOLER
    K Number
    K891603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Alpha Rehabilitation Products
    Date Received
    March 20, 1989
    Decision Date
    July 25, 1989
    Product Code
    ILO
    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
    ILO Pack, Hot Or Cold, Water Circulating

    Similar 510(k) Clearances

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

    Armory Motion

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COOLSKIN

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JUNIPER CLN1 DERMAL COOLING DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFICATION TO POLAR CARE 500

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IVC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all