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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: KNN FDA class 1

    Components, Wheelchair

    Physical Medicine

    View full classification →

    Wheelchair Components are structural and functional parts used to assemble, repair, or modify manual or powered wheelchairs, including frames, wheels, footrests, armrests, and related structural elements that support mobility for individuals with physical disabilities. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket clearance required. The product code is KNN and it is regulated under 21 CFR 890.3920 in the Physical Medicine specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
    DYNASTY GC 12550 (GELL/CELL)
    DYNASTY GC 12400 (GELL/CELL)
    DYNASTY U1-33 AGM
    DYNASTY U1-31 (GELL/CELL)
    ALDEN LINEAGE WHEELCHAIR CUSHION
    ALDEN WHEELCHAIR CUSHION
    ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION
    PM
    RHOMBO MEDICAL RHOMBO-FILL
    TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST
    TILT SEATING SYSTEM
    VALU-PLUS PAD
    NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC
    BIOMEDICAL HORIZONS MODEL 1001
    MANUAL CHAIR BASE
    CUSHION, WHELCHAR AND FLOTATION
    SERENA WHEELCHAIR CUSHIONS
    PIN DOT MOUNTING BRACKETS
    PIN DOT FLIP-DOWN ABDUCTOR
    IMPALA WHEELS
    PIN DOT TRUNION MOUNTS
    PIN DOT GROWTH/DIAL LINKS
    PIN DOT ALUMINUM PAN
    IMPALA AXLES
    ARMREST
    IMPALA CASTERS
    PIN DOT FOOTREST PRODUCTS
    T.C.S. TOTAL CONTACT SEAT
    HANDI-TRAK WHEELCHAIR SNOW CHAINS
    THE CAROLINA ROCKER
    PERSONAL BACK WITH FIP KIT
    WHEELCHAIR STUMP SUPPORT
    E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE
    LAYDOWN ARM SUPPORT MECHANISM
    SLIDING ARM SUPPORT
    REMOVABLE BATTERY POWER SYSTEM
    GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT
    WHEELS-OFF QUICK RELEASE AXLE SYSTEM
    STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT
    LIFESTYLE SOF. CARE GEL CHAIR CUSHION
    VAN-TEC PROSTATE BIOPSY NEEDLE
    REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS
    (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
    UPHOLSTERED BUCKET SEAT
    KINESETHETIC SEATING SYSTEM/WHEELCHAIR
    THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS
    SHS CUSHION/WHEELCHAIR
    BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID
    COMFORTEX WHEELCHAIR CUSHION

    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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