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: INI FDA class 2

    Vehicle, Motorized 3-Wheeled

    Physical Medicine

    View full classification →

    A Motorized 3-Wheeled Vehicle is a powered mobility device designed for individuals with impaired mobility who require a compact, maneuverable alternative to a powered wheelchair, providing independent transportation for persons with lower limb disabilities or reduced walking capacity. 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 INI, regulated under 21 CFR 890.3800, 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
    Virgo Mobility Scooter (Virgo-D,Virgo-F)
    Scooter (YD-03)
    Mobility Scooter (Air Carbon)
    Mobility Scooter (X-12, X-14, X-17)
    Electrical Scooter (SM4226)
    Power Mobility Scooter (MJMA01, MJMA02)
    Mobility Scooter (CL-Q3, CL-Q4)
    Mobility Scooter (S3)
    Electric Scooter (Mojo-T580)
    Electric Scooter (DDF100)
    Electric Scooter (Mojo-T330)
    Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
    Mobility Scooter (BC-MS310)
    Electric Scooter (S202572J, S2060, M2089, S2050)
    Mobility Scooter (T5)
    Powered Mobility Scooter (PMS105, GUT177, GCAT047)
    Folding Mobility Scooter (KD101)
    Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06)
    Mobility Scooter (MS160C)
    Mobility Scooter (JT10)
    Magnesium alloy scooter (RS100)
    Mobility Scooter (Model X-01, X-02)
    Powered Mobility Scooter
    Mobility Scooter (MS160A)
    Mobility Scooter (S-01); Mobility Scooter (S-02)
    Electrical Scooter, WT-T4SU
    Mobility Scooter (YL-09B, YL-07)
    WHILL Model R
    Scooter (PS30)
    Mobility Scooter (N3473)
    Mobility Scooter
    Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
    Electric Scooter (M2085, S2091)
    Mobility Scooter (W3331)
    Mobility Scooter (W3431)
    Mobility Scooter (C4+)
    Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
    Mobility Scooter (Models: W3431D)
    Electric Scooter (Model: M2020)
    ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)
    Electric Scooter (Model: S3312)
    Electrical Scooter, WT-T4QP2
    Mobility Scooter (Models: W3431Q, W3431R)
    eFOLDi Scooter, Lite
    HS186B Scooter
    Mobility Scooter, Model: W3331F
    Auto Folding Scooter, S21F
    Electric Scooter
    Mobility Scooter
    Mobility Scooter, Model W3468

    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

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump