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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: IPF FDA class 2

    Stimulator, Muscle, Powered

    Physical Medicine

    View full classification →

    A Powered Muscle Stimulator is an electrical therapy device used in Physical Medicine to deliver electrical current to skeletal muscles via surface electrodes, causing muscle contractions for purposes such as preventing muscle atrophy, re-educating muscle function, improving circulation, and managing chronic pain. 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 IPF, regulated under 21 CFR 890.5850, 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
    Apollo Quattro (APQ-10M)
    High Tone Power therapy (HiToP) (Model: HiToP PNP)
    StimelMD (SSMD) system
    Compact II
    EVE Synergy (EVE-20M)
    TrainFES Advance
    Quantum Mitohormesis (QMT) (M2101)
    eMVFit (MVF-10M)
    BTL-899MS
    MYOTouch Muscle Stimulator
    Stimulation System (PA series, PR series, S series and Q series)
    accufit
    M-Wave
    BTL-899M
    Stim2Go
    Combo Electrotherapy Device
    NeuroTrigger Basic (NTB)
    accufit
    StarFormer, TightWave
    BACK 4
    DEKA SIMON
    HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
    Flex-MI
    Biological Feedback and Stimulation System
    Shoulder PacemakerTM
    MyOnyx System
    Motive Knee Wrap
    geko W-3
    Levator Elite (Model LE9011)
    TimeWaver Frequency
    geko W-2
    MyoWorx TM20
    STELLA BIO
    Shoulder Pacemaker
    PowerDot PD-01MT2 Muscle Stimulator
    Nerve and Muscle Stimulator
    Intellihab System
    Prelivia
    Neurodyn V2.0, Neurodyn Aussie V2.0
    Talent-Pro Electromagnetic Stimulator
    Storz Medical MAGNETOLITH Muscle Stimulator
    InMode Evolve System with the Tone Applicator
    PowerDot PD-01MT2 Muscle Stimulator
    emField
    Biofeedback Nerve and Muscle Stimulator
    Physiq
    Avid CT2
    g.Estim FES
    Medline DeNovo 4Pro Electrical Stimulation Device
    ETD Family of Electrotherapy Devices

    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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