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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: GZJ FDA class 2

    Stimulator, Nerve, Transcutaneous, For Pain Relief

    Neurology

    View full classification →

    The Transcutaneous Nerve Stimulator for Pain Relief, commonly known as a TENS unit, is a non-invasive device that delivers low-voltage electrical currents through electrodes placed on the skin to modulate pain signals and provide relief from acute and chronic pain. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZJ under regulation 21 CFR 882.5890 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Unipro (K-UNIPRO-US)
    TENSWave
    Electrical Neuromuscular Stimulator, Cure Trio
    Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
    iRelieve Microcurrent Pain Relief System
    StimOnTM Pain Relief System (GM2439)
    Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
    TENS device-EmeTerm 2, Model: YF-ZTY-E2
    Transcutaneous Electrical Nerve Stimulator
    TrueRelief Device
    BioWaveGO RX
    Scrambler Therapy Technology (Model ST-5A)
    actiTENS
    OGYILI TENS/NMES Stimulator
    StimaWELL 120MTRS
    ReliefBand
    ReliefBand
    ClearUP Sinus Pain Relief
    BioWaveGO
    TENS device-EmeTerm, CinvStop
    ReliefBand 1.5
    STIMPOD NMS460 Nerve Stimulator
    WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
    SimulCare II(TM)
    Strive
    FD TENS 2090, FD TENS 2095
    BiowaveHOME Neuromodulation Pain Therapy Device
    Synapse Transcutaneous Electrical Stimulation Device
    Scrambler Therapy MC-5 A Device
    SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
    CP RELIEF WAND
    Best-AV2 Pro-Sport(tm)
    BODIHEALTH SYSTEM
    JIAJIAN POINTOSELECT DIGITAL
    SENSUS
    GEM-STIM COMBO STIMULATOR
    NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
    STERLING MEDICAL IMPULSE 3 STIMULATOR
    WITOUCH PRO
    SENSUS
    ATOM 1 (MODEL: BRC 2200)
    ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
    GEMORE TENS SYSTEM
    ULTIMA NEO
    JIAJIAN TENS
    FD TENS 2070
    NEUROTECH PLUS
    H-WAVE
    FD TENS 2050 OR SLIDE TENS MODEL FD2050
    QUADRA BLOC TENS PLUS

    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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