As you browse through the Rascal® Power Mobility website, you’ll find many references and captions that read FDA Class II Medical Device.

What does this description mean, how is it a distinguishing factor from similar products, and most importantly, why is this something that you should consider when choosing your next electric wheelchair or mobility scooter? Let’s dive into the details.

What is an FDA Class II Medical Device?

The Food and Drug Administration (FDA) plays a critical role in assessing the quality, safety, and effectiveness of products (or devices) that are designed to improve or enhance the lives of those using them. These devices are assigned a class based on risk to the patient – Class I, Class II, Class III.

Electric wheelchairs and mobility scooters fall under Class II, which indicates moderate risk to the patient and requires the manufacturer to demonstrate the product’s equivalence to an existing, legally marketed device. If a product is approved by the FDA, a company can market their product as an FDA Class II Medical Device.

This moniker ensures that a product has undergone thorough testing that adheres to the highest standards for quality, safety, and performance.

What separates Rascal® from the rest?

As you consider your next mobility device, it’s important to understand that not all electric wheelchairs and mobility scooters will receive the “FDA Class II Medical Device” designation. That means the products have not undergone the required testing or the manufacturer hasn’t developed the product with the intention of having a person use it for medical purposes.

As you search for your next mobility solution, especially if you’re browsing online, there are a few ways to determine whether a product is cleared by the FDA. Referring to the Rascal homepage and each product page, you’ll see that all photos and imagery of our products are accompanied by the FDA Class II Medical Device verbiage. If you search for “FDA” in the text of the page, you’ll see numerous mentions.

Every Rascal® product is rigorously tested and approved to meet or exceed FDA and other regulatory standards, so you can enjoy the peace of mind of knowing that you’re receiving a power wheelchair or mobility scooter that will deliver for your individual needs.

Other manufacturers will similarly advertise their products in this manner if they in fact are cleared by the FDA. If you’re researching a product and don’t notice this verbiage anywhere on the product’s webpage, it’s more than likely that the product isn’t cleared by the FDA and therefore does not meet the same quality, safety, and performance standards to which Rascal® products adhere.

Why does this distinction matter to you?

If you’re in need of mobility assistance or are seeking options for a loved one, you should never compromise on quality and performance. Such an investment in your health is too important to cut corners. You need a reliable device that will deliver time and time again.

Rascal® not only offers a quality mobility experience thanks to its approval by the FDA and the tireless work of our Research & Development team, but it remains an affordable option as well. If deciding between two units of similar price, but only one is tagged as an FDA Class II Medical Device, that alone should make the difference.

We take our FDA distinction seriously and strive to have the team in place to support it.

The bottom line.

Any manufacturer can develop a mobility product – not all are able to meet the requirements to receive FDA clearance. Products designed to aid those with mobility impairments carry a higher standard of quality and reliability. It’s why there are several agencies and procedures in place to ensure that any electric wheelchair or mobility scooter classified as an FDA Class II Medical Device is subjected to a long, detailed process.

Rascal® Power Mobility exceeds these standards while remaining an affordable solution for your mobility needs. Browse our site to discover which unit is right for you and start your journey toward quality, comfort, and independence!

Rascal® Power Mobility by Mega Motion® has something to offer everyone seeking greater independence in their everyday lives. Our Carbon Cruiser is a lightweight power wheelchair that folds for convenient portability, our Venture 3-Wheel and 4-Wheel mobility scooters are built for travel, separating into five lightweight pieces with swift release technology, and our Conquest 3-Wheel and 4-Wheel mid-size scooters are built to handle more varied terrain.

No matter your preference or individual needs, Rascal® has you covered with reliable FDA Class II Medical Devices!