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

    THERMOCOOL SYSTEM

    K Number: K950395 · Decision Aug 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    376
    Review Days
    198

    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
    THERMOCOOL SYSTEM
    K Number
    K950395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Zimmer, Inc.
    Date Received
    February 1, 1995
    Decision Date
    August 18, 1995
    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

    Other Clearances by Zimmer, Inc.

    K Number Device Name
    K261683 Augment Off-Axis Instrument System
    K260831 Z1 Hip System
    K251840 Zimmer® Persona® Personalized Knee System
    K260182 Avenir® Müller Stem; Avenir Complete™ Hip System
    K253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
    K253566 Affixus Retrograde Femoral Nailing System
    K253189 Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
    K252623 G7® Revision Acetabular System
    K251098 Identity Revision Humeral Stems
    K251906 Z1 Hip System
    Search all 376 clearances from Zimmer, Inc. →