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

    TECNOL PATIENT USE ICE PACK

    K Number: K760782 · Decision Dec 2, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    35
    Review Days
    58

    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
    TECNOL PATIENT USE ICE PACK
    K Number
    K760782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Tecnol New Jersey Wound Care, Inc.
    Date Received
    October 5, 1976
    Decision Date
    December 2, 1976
    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 Tecnol New Jersey Wound Care, Inc.

    K Number Device Name
    K913043 MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
    K911891 FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
    K911907 FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
    K896193 TECNOL LAZER(TM) SURGICAL MASK
    K894205 TECNOL SILK STRIP
    K893702 TECNOL GAITERS PRODUCT NUMBER 47725-010
    K891187 TECNOL NASO-GASTRIC TUBE HOLDER
    K891178 TECNOL SECURE-ALL TUBE HOLDER
    K884440 TECNOL VARIABLE TENSION BANDAGE
    K882640 TECNOL SECURE-ALL PELVIC TRACTION BELT
    Search all 35 clearances from Tecnol New Jersey Wound Care, Inc. →