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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: ITH FDA class 2

    Equipment, Traction, Powered

    Physical Medicine

    View full classification →

    Powered traction equipment is an electrically or mechanically powered device used to apply sustained or intermittent longitudinal traction to the spine or extremities for decompression and pain relief in musculoskeletal conditions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is ITH, regulated under 21 CFR 890.5900, within the Physical Medicine medical specialty. This device is eligible for third party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DRX9000C-SL Cervical Spinal Decompression System
    Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
    c1Trac
    ELTRAC 471
    Modpod
    ITRAC CERVICAL TRACTION SYSTEM
    INTEGRITY SPINAL CARE SYSTEM 3.0
    EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
    INTEGRITY SPINAL CARE SYSTEM
    DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
    MTD 4000
    TM-400
    GRAVILAX TRACTION SYSTEM
    MODEL D DISC FORCE
    CYCLETRAC CT-5000
    VAX-D GENESIS G2 SYSTEM
    CTBOX CERVICAL/LUMBAR TRACTION
    DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
    TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
    TRACTION SYSTEM, DIGIT-TRAC 930
    VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
    TRITON/TRU-TRAC/TX TRACTION DEVICES
    SPINA SYSTEM
    SPINEMED S200B/S200C
    BASS ANTALGIC-TRAK
    HEALTHSTAR ELITE
    EXTENTRAC ELITE
    SPINERX-LDM
    LORDEX POWER TRACTION EQUIPMENT
    SPINEMED
    DRX3000
    DRX5000
    DRX 2000
    3D ACTIVETRAC
    SPINA SYSTEM
    JILCO TRACTION-FLEXION CHAIR
    SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
    AMT THERAPEUTIC TABLE, MODEL 748AMT
    DYNATRON 900
    HANG UPS POWER II
    AKRON ATP9 TRACTION MACHINE
    TM-300 TRACTION SYSTEM
    CTD MARK I TRACTION DEVICE
    DRS SYSTEM
    VAX-D THERAPEUTIC TABLE
    ATT-300
    ASH-7000
    EXCEL TX
    MINTO SKIN TRACTION MOTOR
    ACCUTRAC TRACTION UNIT

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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