Search Results

I 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.

Electric Scooter (Model: M2020)

The provided text is an FDA 510(k) clearance letter for an electric scooter (Model: M2020) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML-driven medical device.

The document discusses:

• The FDA's determination of substantial equivalence for an electric scooter.
• Regulatory requirements for the device (e.g., registration, listing, labeling, good manufacturing practices).
• The product code (INI) and regulation number (21 CFR 890.3800), which pertain to "Motorized Three-Wheeled Vehicle."
• Indications for Use of the electric scooter: "It 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."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided input does not describe such a device or study.

Ask a specific question about this device