FDA Registration
Active
🇺🇸 United States
DX2 Wheelchair Controller
Reg #: 2081283
·
FEI: 2081283
·
Expires 2025
Products
1
Proprietary Names
56
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- FREEDOM DESIGNS, INC.
- Registration Number
- 2081283
- FEI Number
- 2081283
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2241 MADERA RD.
- City
- SIMI VALLEY
- State
- CA
- ZIP
- 93065
- Country
- US
Owner / Operator
- Firm Name
- Invacare Corporation
- Operator Number
- 1525712
- Address
- One Invacare Way
- City
- Elyria
- State
- OH
- Postal Code
- 44035
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2007-06-22 |
Proprietary Names
DX2 Wheelchair Controller
DX Wheelchair Controller
LiNX® Control System
Mk-6 Wheelchair Controller
Arm Drive
Scissor Assembly
Wireless mouse emulator
Wheel Lock Extensions
PRO LEAF Seat Frame- Right
4-way expansion block (harness for expandable systems)
Drive Only Remote
Foot Activated Tilt
Myon Wheelchair Components
Wheels
Extremity Control
MEC mini joystick
Fork and Straw
Tires
Wireless triple switch receiver
2-Channel Actuator Module
4-Channel Actuator Module
Compact
Brackets
120A, Dual Motor, Power Controller with Lights and 2 Actuator Channels
Controller
Frames
Washers
Ergo Bend Push Handles and Back Post Tubes
PRO SRO Seat Frame- Right
Attendant Control
PRO LEAF Seat Frame- Left
Dual Lever Hand Activated Tilt
Rehabilitation Remote with Colour LCD Display and Touch
Non-Folding Device
Bar Adjustable Spreader
G-Trac / Gyro Wheelchair Controller
Wireless double switch receiver
Hardware
Standard 90 Bend Push Handles and Back Post Tubes
Compact, Single Switch
Compact Remote
Bar Spreader
Front Rigging
Tubes
PRO LEAF Seat Frame- Pair
Grips
Screws
Back Canes
Remotes with LED Display
Atom Proton Head Array
2D Dynamic Footrest Hanger
Compact Remote with Low Force Joystick
4-Switch Proximity
Secondary Color LCD Display with Touch
120A, Dual Motor, Power Controller
Shark Wheelchair Controller
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198