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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: IOR FDA class 1

    Wheelchair, Mechanical

    Physical Medicine

    View full classification →

    A Mechanical Wheelchair is a manually propelled wheeled mobility device used in Physical Medicine to provide seating and independent or attendant-assisted mobility for individuals who are unable to walk or who have limited walking ability, available in a range of configurations including standard, lightweight, and sport models. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IOR, regulated under 21 CFR 890.3850, 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
    Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)
    Bowhead ERA Wheelchairs
    Manual Wheelchair (MASY23)
    Manual Wheelchair (SYIV100-CA9221)
    Manual Wheelchair
    Merlexi Craft Bariatric series of manual wheelchairs
    YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)
    Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)
    Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)
    Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
    Little Wave Clik, Rogue XP, Little Wave XP, Spark
    MA012 Aluminum wheelchair, MS019 steel wheelchair
    Manual Wheelchair (A006)
    Zhenjiang Assure Mechanical Wheelchair,model:K1
    Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
    SUPERTILT PLUS (STP)
    Manual Wheelchair
    RoughRider Aurora Manual Wheelchair
    Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
    Manual Wheelchair (Model W28)
    Manual Wheelchair, Model A011
    RGK Daily Range Wheelchairs
    Manual Wheelchair
    IKON 40 Manual Wheelchair
    Manual Wheelchair SIVFH2A102
    Rowheels Revolution 1.0
    Manual Wheelchair W54
    Element Pediatric Wheelchair
    Manual Wheelchair
    Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
    AST Model MA012 and MS019 Rehab Wheelchair
    Athena 190
    Merits Model R106/R136 Rehab Wheelchair
    Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T
    Wheelchair
    Stellar LEAP
    Winner Transfer Wheelchair
    Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair
    GEN_2 and GEN_3 Mechanical Wheelchairs
    Kuschall K-Series Attract Manual Wheelchair
    Kuschall Champion Manual Wheelchair
    Kuschall Advance Manual Wheelchair
    APEX Manual Wheelchair
    SUNCO Mechanical Wheelchair, model SKW-9003
    Kudu
    Pure Tilt
    Weely Manual Wheelchair
    SUNTEC Mechanical Wheelchair, model ST-WL-1000
    MyOn HC Manual Wheelchair
    P.R.O. CG Manual Wheelchair

    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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