Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616091

FEI Number

1000253203

Entity Name

INVAMEX S.DE R.L. DE C.V.

City/State/Country

REYNOSA Tamaulipas, MX

Establishment Address

Avenida el Puente S/N, Parque Industrial el Puente Manimex, REYNOSA Tamaulipas C.P. 88783, MX

Establishment Type(s)

Manufacture Medical Device

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

N/A

PMA Number

N/A

All Registered Proprietary Names

CS600 Series Bed Invacare Homecare Beds G-Series Bed ETUDE HC Series Bed Topaz Invacare 9000 Topaz Wheelchair Cane Holder Crutch Holder Ride-Lite 9000 Series Wheelchair 9000 SL Anti-Tip Wheel Assembly Anti-Tip Assembly Front Adjustable Rear Anti-Tipper 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 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 Tracer SL Positioning Straps Headrest MyOn Adj Angle and Fold Down Backrest Thoracic Lateral Support (Pair) Backrest MyOn armrests Back Post Mounted Armrests Armrests and Armrest Pads Frame Mounted Armrests Etude HC Trapeze G7740CS Trapeze Bariatric Trapeze CS600 Trapeze IV/O2 HOLDER O2 HOLDER wheelchair tray Invacare® Solara® 3G Manual Wheelchair Tips and Pads 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	Class 2	880.5100	1992-11-19
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2014-02-21
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2014-09-03
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2015-11-04
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2023-10-06
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2007-06-22
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2005-02-08
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2004-10-21
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2014-09-03
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2023-10-06
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2014-09-03
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2005-02-08
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2003-03-13
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	1992-12-23
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2018-11-20
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	1977-12-21
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2007-06-22

Official Correspondent

Dona Bhamra

US Agent Details

Dona Bhamra Business: Invacare Corporation DBA Invacare America Email: Regulatory@invacareamerica.com Phone: (440) 3296000

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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616091. Last updated year: 2026. Please use registration number 9616091 when referencing this establishment in official correspondence.