Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2081283

FEI Number

2081283

Entity Name

FREEDOM DESIGNS, INC.

City/State/Country

SIMI VALLEY, CA, US

Establishment Address

2261 MADERA RD., SIMI VALLEY, CA 93065, US

Establishment Type(s)

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

K952431

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2013-08-09
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	1992-12-23
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2015-10-30
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2007-06-22
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	1992-12-23
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2023-10-06
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2013-08-09

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
3004730072	ALBER GMBH	ALBSTADT Baden-Wurttemberg, DE
1531186	INVACARE CORP. DBA INVACARE AMERICA	ELYRIA, OH, US

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

Similar Registrations

Registration Number	Establishment Name	Location
3015772781	Drive DeVilbiss Healthcare	Palmetto, GA, US
1058397	NEIL MEDICAL GROUP	Kinston, NC, US
1531186	INVACARE CORP. DBA INVACARE AMERICA	ELYRIA, OH, US
3001657382	R82 A/S	GEDVED Midtjylland, DK
2131358	BRUNO INDEPENDENT LIVING AIDS, INC.	OCONOMOWOC, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2081283. Last updated year: 2026. Please use registration number 2081283 when referencing this establishment in official correspondence.