Pacesave 15090

GUDID B314150901

3 wheeled scooter

BURKE, INC.

Assistive scooter, electric-motor-driven

• Primary Device ID: B314150901
• NIH Device Record Key: 991625e1-4026-4ba8-927d-10520a682490
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pacesave
• Version Model Number: Fusion 500
• Catalog Number: 15090
• Company DUNS: 045093101
• Company Name: BURKE, INC.
• 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

Customer Support Contacts

• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B314150901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061912

FDA Product Code

• INI: Vehicle, Motorized 3-Wheeled

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: 2016-09-01

Devices Manufactured by BURKE, INC.

• B313822501 - Scout: 2018-07-06 Power Wheelchair
• B314150351 - Pacesaver: 2018-07-06 3 wheeled scooter
• B314150571 - Pacesaver: 2018-07-06 3 wheeled scooter
• B314150631 - Pacesaver: 2018-07-06 3-Wheeled Scooter
• B314150671 - Pacesaver: 2018-07-06 3 wheeled Scooter
• B314150681 - Pacesaver: 2018-07-06 3 wheeled scooter
• B314150701 - Pacesaver: 2018-07-06 3 Wheeled scooter
• B314150721 - Pacesaver: 2018-07-06 4-Wheeled Scooter