Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1531186

FEI Number

3002889431

Entity Name

INVACARE CORP. DBA INVACARE AMERICA

City/State/Country

ELYRIA, OH, US

Establishment Address

ONE INVACARE WAY, ELYRIA, OH 44035, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Invacare Corporation dba Invacare America (Owner Number: 1525712)

Owner / Operator Contact Address

One Invacare Way, Elyria, OH 44035, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162621

PMA Number

N/A

All Registered 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 2D Dynamic Footrest Hanger 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2015-11-04
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2014-09-03
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-06-01
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2021-03-23
INA	Hill Holder, Wheelchair	Physical Medicine	Class 1	890.3920	2023-10-06
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2023-10-06
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2024-01-11
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2014-09-03
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	1997-02-12
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2023-09-25
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2009-02-25
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2018-12-12
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-01-19
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	1992-12-23
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2005-02-08
LFF	Unit, Activation, Breath Control	Physical Medicine	Class 1	890.3920	2024-02-14
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2006-04-03
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2007-06-22
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	1992-12-23
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2024-01-12
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2020-01-06
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2014-09-03
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2023-10-06
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2005-02-08
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2023-10-06
OSI	Bariatric Bed	General Hospital	Class 2	880.5100	2016-01-18
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2007-06-22
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2015-04-16
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	Class 2	880.5100	1992-11-19
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2017-07-18
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2015-11-04
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2017-04-27

Official Correspondent

Dona Bhamra

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Invacare Corporation dba Invacare America

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007231105	Invacare GmbH	Isny Baden-Wurttemberg, DE
3008370501	Invacare Portugal, Lda	Leca do Balio Porto, PT
3007582653	Invacare UK Ltd.	Bridgend, GB
2081283	FREEDOM DESIGNS, INC.	SIMI VALLEY, CA, US
3004730072	ALBER GMBH	ALBSTADT Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1531186. Last updated year: 2026. Please use registration number 1531186 when referencing this establishment in official correspondence.