Merits S731RS3-ARB

GUDID 00835246009971

Roadster S3 Three Wheel Scooter - Red, With Batteries

Merits Health Products, Inc.

Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven Assistive scooter, electric-motor-driven

• Primary Device ID: 00835246009971
• NIH Device Record Key: 8bf7feb4-dc89-4242-8ad6-41d7b0d822ed
• Commercial Distribution Discontinuation: 2030-09-29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merits
• Version Model Number: S731RS3-ARB
• Catalog Number: S731RS3-ARB
• Company DUNS: 879307148
• Company Name: Merits Health Products, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00835246009971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182471

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

On-Brand Devices [Merits]

• 00835246009995: Roadster S4 Four Wheel Scooter - Red, With Batteries
• 00835246009988: Roadster S4 Four Wheel Scooter - Blue, With Batteries
• 00835246009971: Roadster S3 Three Wheel Scooter - Red, With Batteries
• 00835246009964: Roadster S3 Three Wheel Scooter - Blue, With Batteries