PS Scout 82565

GUDID B314825651

Scout RF TPB

BURKE, INC.

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

• Primary Device ID: B314825651
• NIH Device Record Key: e6fa218e-4032-46a6-b850-02e94b1894e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PS Scout
• Version Model Number: RF TPB
• Catalog Number: 82565
• 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@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com
• Phone: 913-722-5658
• Email: jernst@leisure-lift.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B314825651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982158

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: 2016-09-20

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