Rayhev

GUDID 06976477180016

Yongkang Ruihe Metal Products Co., Ltd.

Assistive scooter, electric-motor-driven

• Primary Device ID: 06976477180016
• NIH Device Record Key: 1337a08a-3822-4285-8654-fe4221e8de6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rayhev
• Version Model Number: R100
• Company DUNS: 619054329
• Company Name: Yongkang Ruihe Metal Products 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: 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	06976477180016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182411

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: 2025-01-17
• Device Publish Date: 2025-01-09

On-Brand Devices [Rayhev]

• 06976477180047: XW-LY001-A
• 06976477180030: R100-2
• 06976477180023: R100-1
• 06976477180016: R100
• 06976477180009: XW-LY001