BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FREEDOM DESIGNS, INC.

    Reg #: 2081283 · FEI: 2081283 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    81
    Establishment Types
    4
    Classifications
    8

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    Registration Details

    Registration Name
    FREEDOM DESIGNS, INC.
    Registration Number
    2081283
    FEI Number
    2081283
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2261 MADERA RD.
    City
    SIMI VALLEY
    State
    CA
    ZIP
    93065
    Country
    US

    Regulatory Submissions

    510(k) Number
    K023574

    Owner / Operator

    Firm Name
    Invacare Corporation dba Invacare America
    Operator Number
    1525712
    Address
    One Invacare Way
    City
    Elyria
    State
    OH
    Postal Code
    44035
    Country
    US
    Correspondent
    Dona Bhamra

    Products

    Device Name Product Code
    Wheelchair, Mechanical IOR
    Cushion, Wheelchair IMP
    Components, Wheelchair KNN
    Board, Lap, Wheelchair IMX
    Device, Anti-Tip, Wheelchair IMR
    Accessories, Wheelchair KNO
    Footrest, Wheelchair IMM
    Armrest, Wheelchair IML

    Proprietary Names

    NXT Tilt-in-Space Mobility Freedom NXT Mini PinDot Custom Seating Systems WHEELCHAIR CUSHION PinDot Silhouette Cushions PinDot ContourU System P.R.O. CG P.R.O. CG Rigid DX Wheelchair Controller DX2 Wheelchair Controller LiNX® Control System Mk-6 Wheelchair Controller Myon Wheelchair Components Grips Wheel Lock Extensions Extremity Control MEC mini joystick Wireless triple switch receiver PRO SRO Seat Frame- Right Scissor Assembly Standard 90 Bend Push Handles and Back Post Tubes Remotes with LED Display Wheels Front Rigging PRO LEAF Seat Frame- Right Back Canes Ergo Bend Push Handles and Back Post Tubes Wireless mouse emulator PRO LEAF Seat Frame- Left Compact Dual Lever Hand Activated Tilt Non-Folding Device Rehabilitation Remote with Colour LCD Display and Touch Tires 4-Channel Actuator Module Drive Only Remote Attendant Control PRO LEAF Seat Frame- Pair Frames 120A, Dual Motor, Power Controller Foot Activated Tilt Tubes 4-Switch Proximity Secondary Color LCD Display with Touch 4-way expansion block (harness for expandable systems) Bar Spreader 120A, Dual Motor, Power Controller with Lights and 2 Actuator Channels Compact Remote with Low Force Joystick Washers Brackets Hardware Arm Drive Compact, Single Switch Compact Remote Atom Proton Head Array 2-Channel Actuator Module Fork and Straw Controller Bar Adjustable Spreader 2D Dynamic Footrest Hanger Screws G-Trac / Gyro Wheelchair Controller Wireless double switch receiver Shark Wheelchair Controller wheelchair tray Anti-Tip Wheel Assembly Anti-Tip Assembly Front Adjustable Rear Anti-Tipper Spectrum 3 IV/O2 HOLDER O2 HOLDER Foot Rests MyOn Legrests MAPS Footplate Mounting Hardware Super Contracture Footrest Hanger Leg Rests MyOn Footrests MyOn armrests Back Post Mounted Armrests Armrests and Armrest Pads Frame Mounted Armrests

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device