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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: ILJ FDA class 2

    Bath, Hydro-Massage

    Physical Medicine

    View full classification →

    A Hydro-Massage Bath is a powered hydrotherapy device used in Physical Medicine that combines water immersion with mechanical agitation or water jets to apply therapeutic massage to the body, used for relaxation, pain relief, wound care, and musculoskeletal rehabilitation. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILJ, regulated under 21 CFR 890.5100, within the Physical Medicine medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PARKER 500
    IMMERSION HYDROBATH
    MBATH 1000 (60)
    PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
    SUPERIOR BATH, MODEL 6300
    CASCADE BATH, MODEL 6900
    RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
    VANNA BATHING SYSTEM
    A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
    HYDROTONE-THERMAL CAPSULE SYSTEM
    VICHY SHOWER
    EQUINOXE
    HYDROTONE
    FERNO HEALTHCARE RECLINE-A-BATH 2
    WINDMERE MODEL DS-2 FOOT BATH
    XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
    SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
    BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
    FREEDOM BATH
    CENTURY BATHING SYSTEM
    AQUADYNE
    THERA-FIT
    MALIBU BATHING SYSTEM
    AQUACISER II
    SANITAS WHIRPOOL BATHING SYSTEM
    NO CROSS CONTAM HYDROTHERAPY TANK LINER
    ARJO-CENTURY ARM AND LEG TANK SYSTEM
    FULL MOVEMENT THERAPY SYSTEMS
    ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
    AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS
    FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403
    AMISH COUNTRY SPA
    SHOWER MINI RD-7 SANITARY WASHER
    JETTA JR. HYDRO MASSAGE
    PACIFIC MARQUIS SPA
    SPA SHELL
    LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH
    AQUACISER SYSTEM
    HYDROTONE I
    SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM
    PARKER BATHING SYSTEM
    MODEL 938 BATHING SYSTEM
    WHIRLPOOL AERATOR WB700, WB800, WB900, WB975
    CRYOTHERM
    AQUA ARK, IMMERSION HYDROBATH
    SETMA HYGIA BATH MODEL ST 7200
    SETMA FHT, MODEL ST 8130
    SETMA VHT
    MEDO BUBBLE BATH MA-80, 400, 600 & 700
    MULTIPLE PLANETAMED;PLANETA HYDROMASS

    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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