Paragolfer Power Wheelchair

GUDID 04064406193656

Otto Bock Mobility Solutions GmbH

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

• Primary Device ID: 04064406193656
• NIH Device Record Key: e920c741-facb-44d3-85e0-bf3ae3b67cc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragolfer Power Wheelchair
• Version Model Number: 490E54=00000_K
• Company DUNS: 341148586
• Company Name: Otto Bock Mobility Solutions GmbH
• 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: true
• 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
GS1	04064406193656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060936

FDA Product Code

• IPL: Wheelchair, Standup

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: 2020-09-23
• Device Publish Date: 2020-09-15

On-Brand Devices [Paragolfer Power Wheelchair]

• 04032767402526: 490E54=00000_X
• 04032767048397: 490E54=00000_K
• 04064406193656: 490E54=00000_K