BEUDAMED
    Product Code: KQZ FDA class 1 21 CFR 888.5890

    Component, Traction, Non-Invasive

    Orthopedic

    This device is a non-invasive traction component used as part of a traction system to apply mechanical force to the spine or limbs to relieve pain, reduce joint compression, or manage musculoskeletal conditions without penetrating the skin. It is classified as FDA Class 1, the lowest risk level, subject to general controls. The product code is KQZ, regulated under 21 CFR 888.5890 within the Orthopedic specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    11
    FEI Numbers
    108
    Registration Numbers
    108
    Unique Applicants
    10
    Years Active
    10

    Basic Information

    Product Code
    KQZ
    Device Class
    FDA class 1
    Regulation Number
    888.5890
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    4

    Device Characteristics

    ✓
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K884132 TECNOL BUCKS TRACTION W/HEEL PROTECTOR
    K882640 TECNOL SECURE-ALL PELVIC TRACTION BELT
    K871900 OVER DRAPE LEG HOLDER
    K871296 T.E.D.(TM) TRACTION DEVICE
    K854270 MURPHY ADJUSTABLE SPLINT
    K831002 TPG 1000
    K823660 UNIVERSAL BUCKS TRACTION
    K823163 UNIVERSAL BUCKS TRACTION
    K821252 HOFFMAN UNIVERSAL FOOT SUPPORT
    K802869 BACKTRAC 90-90 TRACTION
    K781754 SPLINT, HOAKE INFLATABLE AIR

    FEI Numbers

    This FDA classification entry is associated with 108 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 108 registration numbers. Click on an entry to view related FDA registrations.