BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INVACARE CORP. DBA INVACARE AMERICA

    Reg #: 1531186 · FEI: 3002889431 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    194
    Establishment Types
    4
    Classifications
    31

    Registration Details

    Registration Name
    INVACARE CORP. DBA INVACARE AMERICA
    Registration Number
    1531186
    FEI Number
    3002889431
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    ONE INVACARE WAY
    City
    ELYRIA
    State
    OH
    ZIP
    44035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K002170

    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
    Handrim, Wheelchair IMO
    Wheelchair, Powered ITI
    Hill Holder, Wheelchair INA
    Support, Head And Trunk, Wheelchair IMS
    Armrest, Wheelchair IML
    Mattress, Air Flotation, Alternating Pressure FNM
    Restraint, Protective FMQ
    Mattress, Flotation Therapy, Non-Powered IKY
    Board, Lap, Wheelchair IMX
    Aid, Transfer IKX
    Unit, Activation, Breath Control LFF
    Walker, Mechanical ITJ
    Components, Wheelchair KNN
    Cushion, Wheelchair IMP
    Cover, Mattress (Medical Purposes) FMW
    Footrest, Wheelchair IMM
    Brake, Extension, Wheelchair IMW
    Adaptor, Hygiene ILS
    Restraint, Wheelchair, Non-Protective KID
    Bariatric Bed OSI
    Lift, Patient, Non-Ac-Powered FSA
    Bed, Therapeutic, Ac-Powered, Adjustable Home-Use LLI
    Tips And Pads, Cane, Crutch And Walker INP
    Chair, With Casters INM
    Climber, Curb, Wheelchair IMN
    Holder, Crutch And Cane, Wheelchair IMZ
    Device, Anti-Tip, Wheelchair IMR
    Belt, Wheelchair IQB
    Adult Portable Bed Rails For Medical Purposes QTC
    Accessories, Wheelchair KNO

    Proprietary Names

    9000 Jymni Pediatric Manual Wheelchair Model 9000 Pediatric Manual Wheelchair MyOn Handrim Handrim Essentials Recliner Wheelchair Invacare® Storm Torque RX Power Wheelchair Wheel Lock Hill Holder Hi Mount Headrest MyOn Adj Angle and Fold Down Backrest Thoracic Lateral Support (Pair) Backrest Invacare Essentials SX3 Invacare Essentials EX1 MyOn armrests Back Post Mounted Armrests Armrests and Armrest Pads Frame Mounted Armrests Invacare® Softform Premier Active 2 mattress with RX pump microAIR® Low Air Loss System Invacare® Softform Premier Active 2 mattress Invacare® Alternating Air Mattress & Pump with Static Mode Invacare® Alternating Air Mattress & Pump Pelvic Restraint Aquatec Ocean Glissando Mattress Invacare Essentials Mattress Invacare® Softform Premier Mattress Invacare® Solace Mattress Invacare TDX SPV2-HD with Captain's Seat Easy Glide Wheelchair for Invacare wheelchair tray Etude HC Trapeze G7740CS Trapeze Bariatric Trapeze CS600 Trapeze Sip-n-Puff Head Array Input Module with Integrated Sip-n-Puff DOLOMITE MAXI +550 ROLLATOR Dolomite Legacy 600, Red (C) DABS-Brake, Ergo Grip, SL II Wheel Basket, Back support, Curb climber Dolomite Legacy 520, Blue (C) DABS-Brake, Ergo grip SL II Wheel Basket, Back support, Curb climber DOLOMITE MAXI +650 W/CURB CLIMBER Dolomite Legacy 450, Blue (C) DABS-Brake, Soft grip SL II Wheel Basket, Back support, Curb climber DOLOMITE MAXI +550 W/CURB CLIMBER Dolomite Legacy 450, Red (C) DABS-Brake, Soft grip SL II Wheel Basket, Back support, Curb climber Dolomite Cane Holder DOLOMITE LEGACY 600 VA Dolomite Legacy 520, Red (C) DABS-Brake, Soft grip SL II Wheel Basket, Back support, Curb climber DOLOMITE MAXI +650 ROLLATOR DOLOMITE LEGACY 600 VA W/O BASKET Invacare Essentials Rollator 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 PinDot Custom Seating Systems WHEELCHAIR CUSHION PinDot Silhouette Cushions PinDot ContourU System Invacare® Softform Premier Foam Mattress Cover Invacare® Solace Mattress Cover Invacare® Aviva FX Power Wheelchair Foot Rests MyOn Legrests MAPS Footplate Mounting Hardware Super Contracture Footrest Hanger Leg Rests MyOn Footrests MyOn Brake Extension Brake Extension E-Motion Version 2 Daily Activity Assist Device Trans Disk INVACARE GRAY SPLASH SHIELD Invacare Vinyl Padded Shower Chair Drop Arm Stationary Commode Invacare Folding Shower Chair with Back Aquatec Ocean Dual-VIP Invacare Shower Chair Aquatec Ocean E-VIP Aquatec Ocean VIP Ocean Ergo VA Ocean VIP Ergo Dir. Lock VA Overbed Table Ocean Ergo XL Dir. Lock Mariner Series Ocean Dual-VIP Ergo Dir. Lock VA Positioning Belt IVC BARIATRIC BED LIFT POWER RELIANT 600 LOW W/ POWER BASE LIFT RELIANT 350 POWER LOW BASE Get-U-Up Hydraulic Stand-Up Lift LIFT RELIANT 600 POWER LOW BASE LIFT POWER RELIANT 450 LOW W/ POWER BASE HYDRAULIC LIFT W/ADJ BASE BEIGE LIFT POWER RELIANT 350 LOW W/ POWER BASE LIFT RELIANT 450 HYD LOW BASE I LIFT POWER LIFT W/POWER BASE LIFT RELIANT 450 POWER LOW BASE Reliant Lift Range 9805P Hydraulic Lift ISA™ XPLUS Stand Assist Lift Invacare® Stand Assist ISA™ Lifter ISA™ COMPACT Invacare® Birdie®EVO COMPACT Birdie® EVO XPLUS Mobile Floor Lift Aquatec® XL Aquatec® R Aquatec® SRB Aquatec Orca Aquatec J TDX SP2 CS600 Series Bed Invacare Homecare Beds G-Series Bed ETUDE HC Series Bed TDXSP2-CG TDX® SP2 Base for Single Actuator System w/ Ultra Low Maxx TDXSP2 TDX® SP2 with LiNX Electronics Invacare® TDX® SP2 Power Wheelchair Invacare® TDX SP2™ with Motion Concepts Ultra Low Maxx Power Positioning TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx TDXSP2V: TDX SP2 with Captains Seat Ride-Lite 9000 Series Wheelchair 9000 SL Invacare Tracer SX5 Manual Wheelchair Invacare Tracer SX5 Recline Manual Wheelchair Invacare Tracer IV Heavy Duty Manual Wheelchair Invacare Tracer EX2 Wheelchair Tips and Pads Invacare Three-position Recliners Easy Glide Transport Chair for Invacare Curb Climber Topaz Invacare 9000 Topaz Wheelchair Invacare® Solara® 3G Manual Wheelchair Tracer SL Cane Holder Crutch Holder Anti-Tip Wheel Assembly Anti-Tip Assembly Front Adjustable Rear Anti-Tipper Positioning Straps Thinksoft Positioning Device IV/O2 HOLDER O2 HOLDER

    Establishment Types

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