iBOT

GUDID 00857584008003

iBOT® Personal Mobility Device - Wheelchair, Stair Climbing

MOBIUS MOBILITY LLC

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

• Primary Device ID: 00857584008003
• NIH Device Record Key: cc2af249-b06c-4c35-98fa-c9d57158ae26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iBOT
• Version Model Number: iBOT PMD
• Company DUNS: 081155071
• Company Name: MOBIUS MOBILITY LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857584008003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172601

FDA Product Code

• IMK: Wheelchair, Stair Climbing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-16
• Device Publish Date: 2020-01-08

Devices Manufactured by MOBIUS MOBILITY LLC

• 00857584008010 - iBOT(R): 2022-06-14 iBOT® Personal Mobility Device - Wheelchair, Stair Climbing
• 00857584008003 - iBOT: 2020-01-16iBOT® Personal Mobility Device - Wheelchair, Stair Climbing
• 00857584008003 - iBOT: 2020-01-16 iBOT® Personal Mobility Device - Wheelchair, Stair Climbing