(201 days)
To PROVIDE FOR THE CONSUMING POBLIC, SELF-CONTAINED, COMPACT PERSONAL MOBILITY VEHICLE FOR PERSONS WHO ARE UNABLE TO AMBULATE EITHER BECAUSE OF MEDICAL NECESSITY OR THROUGH PERSONAL PERSONAL PREFERENCE VEHICLE IS OPERABLE BOTH INDOORS AND OU FOR OUTDOOR USAGE. PRIMARILY INTENDED
The Hoveround Activa is a motorized three wheeled scooter. It is battery operated from two rechargeable lead-acid batteries. It consists of a platform which connects the three wheels, ( one at the center front, one each on the rear left and right sides ), an adjustable tiller and a seat for the operator. The device can carry a sole seated operator of maximum weight 300 LB and is driven by using hand controls located at the top of the tiller also acting to steer the vehicle. A battery charger is provided with each model to replenish batteries.
This document is a 510(k) summary for a motorized three-wheeled scooter called the Hoveround Activa. It seeks to establish substantial equivalence to a predicate device. The information provided heavily focuses on regulatory aspects and device description, and does not contain any details about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and studies from the provided text. The document is for a medical device approval pathway that relies on equivalence to a previously approved device, rather than a clinical trial demonstrating performance against specific clinical acceptance criteria.
To answer your request based on the provided document, the response would be:
- No acceptance criteria or study details are present in the provided text.
If this were a different kind of submission (e.g., for a novel diagnostic or AI-powered device), the information would typically be found in sections detailing performance data, clinical studies, or non-clinical tests. This particular document focuses on regulatory compliance and device description for a motorized scooter.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).