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: IPL FDA class 2

    Wheelchair, Standup

    Physical Medicine

    View full classification →

    A Standup Wheelchair is a specialized powered or manual wheelchair designed to transition the user from a seated to an upright standing position while remaining in the device, used in Physical Medicine to provide health benefits of standing including bone density maintenance, circulation improvement, and pressure relief, while retaining mobility. 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 IPL, regulated under 21 CFR 890.3900, 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
    Walking rehabilitation training electric wheelchair (ZW518)
    Action Trackchair Hawk
    ParaMotion
    Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
    Explorer Mini
    F5 Corpus VS
    UPnRIDE
    Modular Power Standing System
    Quickie(r) Q700-UP M
    Action Trackstander models TR1816, TR1820, TR2016, and TR2020
    Tek RMD (Tek Robotic Mobilization Device)
    E-TENG MODEL EOR 1
    HIROLLER ELEVATING WHEELCHAIR
    COMFORT STANDING WHEELCHAIR, HERO SERIES
    POWER STANDING DANI
    LEVO C3
    BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
    LLOYD LINDEN, MODEL E04
    WHEELCHAIR MODEL STS
    LSC, MODEL 3
    PARAGOLFER
    ALILIFE STAND UP POWERED WHEELCHAIR, HC-300
    LEVO COMFORT II
    LSA HELIUM
    LSC LIFESTAND COMPACT
    POWERSTAND STAND-UP WHEELCHAIR
    HERO 1, MODEL LY-ESB220
    COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
    RABBIT MOBILE STANDING FRAME
    LEVO COMBI
    NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
    VERTRAN STANDING WHEELCHAIR
    NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
    STANNAH POWER CHAIR, MODEL 201
    THE LIBERATOR
    LEVO MOBIL LCM
    LEVO COMPACT-EASY LCE
    LEVO ACTIVE-EASY LAE
    BOBCAT DX
    LEVO COMPACT LC
    SUPERSTAND STAND-UP WHELLCHAIR
    CHIEF SR
    CHIEF STANDUP WHEELCHAIR
    REGAIN STAND-UP WHEELCHAIR
    ECONOSTAND
    STANDUP WHEELCHAIR
    MOBILE STANDING FRAME
    TAYLOR MADE MOBILE STANDER
    RIFTON MOBILE PRONE STANDERS
    THE EXCELSIOR

    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