Zip'r 4

GUDID 06972356130141

Zip'r 4 Wheel XTRA Traveler Mobility Scooter blue 10017016

GLOBAL FABTECH (SHANGHAI) CO., LTD.

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06972356130141
• NIH Device Record Key: c6fcbab7-c6b1-4d11-ae64-1602d5bef39e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zip'r 4
• Version Model Number: 01
• Company DUNS: 529966574
• Company Name: GLOBAL FABTECH (SHANGHAI) 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: true
• 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	06972356130141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102361

FDA Product Code

• INI: Vehicle, Motorized 3-Wheeled

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: 2023-10-02
• Device Publish Date: 2023-09-24