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: NGX FDA class 2

    Stimulator, Muscle, Powered, For Muscle Conditioning

    Physical Medicine

    View full classification →

    The Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX) is a powered physical medicine device used to apply electrical stimulation to muscles for conditioning, toning, or rehabilitation purposes, as distinct from devices intended for pain management or therapeutic neuromuscular stimulation. Per its definition, it is used for non-therapeutic muscle conditioning applications. It is classified as an FDA Class 2 device within the Physical Medicine specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Pure Impact
    XBody Go USA, XBody Pro USA
    Muscle Stimulator Device (PZ-100)
    Limfa Therapy System (Limfa Therapy)
    SofWave System
    Wireless TENS & EMS Unit
    EMS (FlexPulse, MagnaCore, Magnetika)
    OTC TENS & EMS Unit
    Pepper EMS Training System
    Tens & Ems Device (TU1080)
    EMS Sculpt Machine
    Neo Sculptor (OF-NEO001)
    SofWave System
    PTG-05
    Pain Therapy Device(Model: P.T.S-X)
    Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
    Electromagnetic Stimulation Systems
    Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
    Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
    Coresculpt & Magsculpt
    Electronic Muscle Stimulator (Model MP01)
    EMS Neck Massager
    DEKA LILY
    HI-EMT MAGSHAPE
    Nova HD+
    Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
    Fitness Belt (Model: KLT-07)
    Bemer Therapy System Evo
    Gnesis EMS Plus
    Powered Muscle Stimulator (Model name:MagGraver F200)
    Visionbody
    Neuro20 Pro System
    XBody Go USA, XBody Pro USA
    truSculpt flex
    CoreLevee
    Miha Bodytec II
    WiEMSpro
    I-Motion
    CoolTone
    Revitive Medic Coach (Model Number 5575AQ)
    Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
    Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
    Legend Pro DMA
    E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
    Pain Therapy Device
    MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
    miha bodytec II
    SLENDERTONE Evolve Abs, Type 735
    BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
    Gymform Total ABS

    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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