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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: IMG FDA class 2

    Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

    Physical Medicine

    View full classification →

    A Stimulator combining Ultrasound and Muscle functions for applying therapeutic deep heat is a Physical Medicine device that delivers both ultrasonic energy and neuromuscular electrical stimulation simultaneously, used to treat musculoskeletal pain, promote tissue healing, and increase deep tissue temperature. 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 IMG, regulated under 21 CFR 890.5860, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
    ComboRehab
    BTL-4000
    SONICSTIMU COMBO THERAPEUTIC DEVICE
    SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
    FUTURA
    SONICATOR PLUS 920
    WINSTIM
    CT2011 SONICSTIMU PAIN RELIEF DEVICE
    SONICATOR PLUS 940, MODEL ME940
    TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
    SONIC-STIM
    DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM
    VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER
    DERMAWAVE 5000 COMBI MAX SYSTEM
    VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
    VECTORSONIC, MODEL VU-270
    RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
    VECTORSONIC, MODEL VU-200
    ULTRA V THERAPEUTIC ULTRASOUND
    VECTRA COMBO
    FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
    FORTE
    FORTE CB
    SONICATOR 730
    FORTE US
    DYNATRON 150
    FORTE US
    DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR
    SONICATOR 716
    THERAPEUTIC ULTRASOUND AND STIMULATOR
    SONICATOR 715
    DYNATRON 800
    SONOPULS 591
    SONICATOR PLUS
    ULTRA III
    DYNATRON 300 ULRASOUND
    MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED
    INTELECT, MODEL 245
    INTELECT 750 MP
    INTELECT 170
    CURAPULS 403 DIATHERMY UNIT
    ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
    OMNISOUND(TM) 3000
    SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION
    SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
    STIMULATOR, ULTRASOUND AND MUSCLE
    FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND
    RICH-MAR DELTA 330 HV
    OMNISTIM II COMBIN. THERAPY SYS

    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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