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The FR-L05 (Luggie Super) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

The FR-L05 (Luggie Super) is a battery-powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-L05 (Luggie Super) is meant to be used by a single rider weighing up to 360 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that has several height adjustments. The steering and user controls are provided on the steering tiller/handlebars for ease of use by the rider. Steering is controlled simply by turning the handlebars in the desired direction. There are two thumb levers, and speed knobs on the tiller console to control movement speed of the scooter. The FR-L05 (Luggie Super) has a controller and 1 lithium battery. There is also an off-board battery charger.

This document is a 510(k) summary for the Freerider Corporation's Luggie Super, a motorized three-wheeled vehicle. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of device performance related to a diagnostic or therapeutic function. This document is for a mobility device (electric scooter). The "testing" mentioned refers to non-clinical bench testing to ensure the device meets safety standards for motorized vehicles and electrical components, not performance criteria for a medical diagnostic or therapeutic function.

Therefore, I cannot provide the requested information in the format of the table and study details, as they are not applicable to the content of this document.

Here's why the requested information cannot be found:

• Type of Device: The Luggie Super is a motorized three-wheeled vehicle (electric scooter) for transportation. It is not a diagnostic device (e.g., AI for image analysis) or a therapeutic device with specific performance metrics like sensitivity, specificity, accuracy, etc.
• "Acceptance Criteria" in this context: For a device like an electric scooter, "acceptance criteria" primarily relate to safety standards (e.g., electromagnetic compatibility, stability, braking performance) and operational specifications (e.g., weight capacity, speed). These are typically met through engineering design and bench testing against established industry standards.
• "Study that proves the device meets the acceptance criteria": The document states "Non-clinical Testing" was conducted, referencing various ISO and IEC standards (e.g., ISO 7176, IEC 60601-1, electromagnetic interference testing). This testing is the "study" that proves it meets the relevant safety and performance standards for a motorized mobility device. The conclusion states: "The safety and effectiveness of the FR-L05 (Luggie Super) was demonstrated by the testing in compliance with national and international standards."
• Lack of Clinical Testing: The document explicitly states, "No clinical testing is included in this submission." This further confirms that its "performance" is not measured in a clinical context that would require ground truth, experts, and statistical metrics like those used for diagnostic AI.
• Lack of AI/Algorithm: This document does not pertain to an AI-powered device or algorithm. Therefore, questions regarding standalone performance, human-in-the-loop, training sets, adjudication, or ground truth for diagnostic purposes are irrelevant.

In summary, the provided text describes a regulatory submission for a simple mobility device. The "acceptance criteria" are compliance with safety and engineering standards, and the "study" consists of non-clinical bench testing against those standards.

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