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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: GZI FDA class 2

    Stimulator, Neuromuscular, External Functional

    Neurology

    View full classification →

    The External Functional Neuromuscular Stimulator is a non-implanted device that delivers electrical stimulation to nerves or muscles through surface electrodes to produce functional movement, used in rehabilitation of patients with conditions such as stroke-related hemiplegia or foot drop. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZI under regulation 21 CFR 882.5810 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Synchrony (20-3000)
    CIONIC NEURAL SLEEVE (NS-200)
    Neuvotion NeuStim NN-01
    MyndMove, MyndMove 2.0
    EvoWalk 1.0 System
    Cionic Neural Sleeve NS-100
    MyoCycle MC-2 (Home / Home + / Pro / Pro +)
    MyndMove 2.0
    Cionic Neural Sleeve NS-100
    MStim Drop Model: LGT-233
    Nerve and Muscle Stimulator
    L100 Go System
    L360 Thigh System
    L300 Go System
    L300 Go System
    ODFS Pace XL
    Foot Drop System (Model XFT-2001D)
    MyndMove System, MyndMove Functional Electrical Stimulator
    RT300 FES cycle ergometer
    MyoCycle Home, MyoCycle Pro
    RehaStim 2
    L300 Go System
    ReGrasp
    MYGAIT STIMULATION SYSTEM
    WALKAIDE SYSTEM
    NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
    REHASTIM 2, ERIGOPRO (FES)
    H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
    WALKAIDE SYSTEM
    NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT
    NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
    REHASTIM 2, REHAMOVE 2
    NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
    L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
    RT200
    RT600
    ODFS PACE
    RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
    MODIFICATION TO:NESS L300
    REHASTIM & REHAMOVE
    RT300-S AND RT300-SP FES CYCLE ERGOMETER
    RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
    RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
    NESS L300
    RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
    WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
    THE ODFS DROPPED FOOT STIMULATOR
    FES CYCLE ERGOMETER, MODEL RT300-S
    HANDMASTER
    MODIFICATION TO HANDMASTER

    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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