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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: IMI FDA class 2

    Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

    Physical Medicine

    View full classification →

    Ultrasonic Diathermy for Applying Therapeutic Deep Heat is a Physical Medicine device that uses ultrasonic energy to generate deep tissue heating within muscles and joints, used to relieve pain, reduce muscle spasm, increase tissue extensibility, and promote healing of soft tissue injuries. 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 IMI, regulated under 21 CFR 890.5300, 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
    Ultrasound Stimulator
    Sonopuls 190
    ManaSport+
    ManaSport
    Sonomed IV, Sonomed V
    BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
    JAS Pulse(TM) Ultrasonic Therapy
    Accent XL
    MC1 Plus
    UltraTENS
    SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
    SONOPULSE/ SONOPULSE III
    ACCUSONIC ADVANTAGE
    ACCUSONIC ADVANTAGE
    US-101L, US-103S
    MED CONTOUR
    SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
    HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
    MED SCULPT
    DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
    SONICATOR 740, MODEL ME 740
    HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
    HES ULTRASONIC THERAPY APPLIANCE
    VECTRA (INTELECT) EPR ULTRASOUND
    SUN-RAIN ULTRASONIC THERAPY, SU-100
    DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
    US-100 PORTABLE ULTRASOUND THERAPY UNIT
    DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
    ACCOUSONIC, MODEL AS-270
    ACCOUSONIC PLUS, MODEL AP-170
    RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
    SONICATOR PLUS 930, MODEL ME 930
    XUB EXTERNAL ULTRASOUND
    MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
    ACCUSONIC, MODEL AS-260
    SONIC MODEL SO-300
    SW ULTRASOUND, MODELS 331, 311, 333
    SONIC, MODEL SO-100
    ENRAF-NONIUS SONOPULS 190 SYSTEM
    ACCUSONIC PLUS, MODEL AP-100
    NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
    EXONIX
    SD-956 ULTRASOUND THERAPY
    RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
    FORTE, MODEL CPS ULTRASOUND
    INTELECT LEGEND ULTRASOUND
    ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
    DYNATRON 125 ULTRASOUND
    CUSHMAN MANUFACTURING, INC. ULTRA 6.0.
    MATRIX MICROSON 410

    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.

    Popular Product Codes

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