Extreme X8 Electric Wheelchair

GUDID B391X80

Extreme X8 Electric Wheelchair

MAGIC MOBILITY

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

• Primary Device ID: B391X80
• NIH Device Record Key: 8a29de16-f1e3-482e-9d18-cdb0ee7c56d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extreme X8 Electric Wheelchair
• Version Model Number: X8
• Company DUNS: 752816785
• Company Name: MAGIC MOBILITY
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B391X80 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090350

FDA Product Code

• ITI: Wheelchair, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-24

On-Brand Devices [Extreme X8 Electric Wheelchair]

• B391X80: Extreme X8 Electric Wheelchair
• 09356399000048: Extreme X8 Electric Four Wheel Drive Wheelchair