iBOT(R)

Basic Information

• Brand Name: iBOT(R)
• Primary DI: 00857584008010
• Version / Model: iBOT PMD
• Company Name: MOBIUS MOBILITY LLC
• Labeler DUNS: 081155071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-06
• Public Version: 1
• Public Version Date: 2022-06-14
• Public Version Status: New
• Public Device Record Key: f77641ad-8d97-454a-9452-91d7a6b3b4ee

Device Description

iBOT® Personal Mobility Device - Wheelchair, Stair Climbing

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: No
• 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
IMK	Wheelchair, Stair Climbing	Physical Medicine	890.3890	2
ITI	Wheelchair, Powered	Physical Medicine	890.3860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41877	Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device cannot be folded or readily dismantled for transport.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857584008010	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius