NAVIONE

GUDID 04580027190046

YAMAHA MOTOR CO., LTD.

Wheelchair electric-motor-driven propulsion system

• Primary Device ID: 04580027190046
• NIH Device Record Key: 67f8e38b-b935-40ed-a814-8417a46fed8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAVIONE
• Version Model Number: X0EJ
• Company DUNS: 690536081
• Company Name: YAMAHA MOTOR CO., LTD.
• 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: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 714-229-7959
• Email: info@yamahanavi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580027190046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140204

FDA Product Code

• ITI: Wheelchair, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-03

On-Brand Devices [NAVIONE]

• 04580027190053: X0EJ
• 04580027190046: X0EJ
• 04580027190039: X0EJ
• 04580027190022: X0EJ
• 04580027190015: X0EJ