INVACARE® TDX® POWER WHEELCHAIR

Basic Information

• Brand Name: INVACARE® TDX® POWER WHEELCHAIR
• Primary DI: 00841447101321
• Version / Model: TDXSIV-2-S
• Company Name: INVACARE CORPORATION
• Labeler DUNS: 076916246
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 5
• Public Version Date: 2023-10-02
• Public Version Status: Update
• Public Device Record Key: 261b5844-0e32-4ed8-8537-a90141ed7fcc
• Distribution End Date: 2016-12-31

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITI	Wheelchair, powered	Physical Medicine	890.3860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41875	Electric-motor-driven wheelchair, occupant-controlled	An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841447101321	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K023589	000