BEUDAMED
    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: JFB FDA class 2

    Table, Physical Therapy, Multi Function

    Physical Medicine

    View full classification →

    A Multi-Function Physical Therapy Table is an adjustable treatment table used in physical and rehabilitative medicine settings to position patients for a variety of therapeutic procedures including manual therapy, exercise, traction, and electrotherapy. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, requiring 510(k) premarket notification. The product code is JFB, regulated under 21 CFR 890.5880, 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
    Ceragem Automatic Thermal Massager (CGM MB-2401)
    AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
    Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
    Ceragem Automatic Thermal Massager (CGM-MB-1902)
    N7-S
    Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
    Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
    Ceragem Automatic Thermal Massager, Model CGM-MB-1901
    N5-1
    CERAGEM AUTOMATIC THERMAL MASSAGER
    LEGACY-500
    CHOYANG THERMAL MASSAGER
    ACQPOINT THERMAJADE MASSAGE TABLE
    NM-7000
    THERMAL MASSAGE BED, MODEL 2D-GX
    VIBRO-TRAC
    INAREX, MODEL 2D-LX
    MASSAGE MATTRESS VM9100RM
    AIR-FLEX WITH AUTO-DISTRACTION
    CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
    CERAGEM-C THERMAL ACUPRESSURE MASSAGER
    THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
    THERMASSAGE ENERGY PRODUCT, MODEL HY5000
    MAGNUM
    QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
    QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
    EXTENTRAC
    P.T. MACHINE
    HANDIFLEX
    THE HILL ADJUSTABLE AIR-FLEX MODEL
    MODELS 4100 AND 4300 MULTITHERAPY
    EURO TECH STERLING ROLLER TABLE
    COMBI 2.5 INTERSEGMENTAL TRACTION TABLE
    HERITAGE 10
    TRACTION TABLE MODEL #825-200
    TRUE-TRAC, STRATUS
    745-M (MAGNUM)
    INTERSEGMENTAL TRACTION TABLE
    PNEU-WAVE
    TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE
    COMFORTRAC TABLE MODEL CT-1000
    PRO TREATMENT TABLE
    IST-200 INTERSEGMENTAL TRACTION TABLE
    PRENATAL WEDGE
    MODEL 1080 ROLLER MASSAGE TABLE
    HI-LO TABLE, MODEL 820-05
    MULTI-FLEX TABLE--MODEL 200
    HEALTHTRONIC OMEGA TRAC
    MULTI-FLEX TABLE -- MODEL 104
    MULTI-FLEX TABLE -- MODEL 106

    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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