LEVO

Basic Information

• Brand Name: LEVO
• Primary DI: 07613045071503
• Version / Model: C3
• Catalog Number: LEVO C3/32
• Company Name: LEVO AG Wohlen
• Labeler DUNS: 481093706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-09
• Public Version: 1
• Public Version Date: 2025-09-17
• Public Version Status: New
• Public Device Record Key: 01db905c-71cc-4317-9024-1f041d9d1c0e

Device Description

Powered Standup Wheelchair.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
IPL	Wheelchair, Standup	Physical Medicine	890.3900	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	07613045071503	GS1

Premarket Submissions

Submission Number	Supplement Number
K083017	000