So Lite S1 Scooter

GUDID 06974386930869

This scooter is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Suzhou Master Machinery Manufacturing Co.,Ltd.

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• Primary Device ID: 06974386930869
• NIH Device Record Key: 4884d95b-b0cb-4c07-a01e-4901743d157c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: So Lite S1 Scooter
• Version Model Number: HS186B
• Company DUNS: 543596952
• Company Name: Suzhou Master Machinery Manufacturing 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974386930869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222711

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: 2024-05-30
• Device Publish Date: 2024-05-22