JTE Mobility’s JT10 Mobility Scooter Receives FDA Class II Medical Device Classification

August 07, 2025 at 12:02 PM EDT

This is a significant achievement for JTE Mobility, as it means the JT10 scooter has met the rigorous standards set by the U.S. Food and Drug Administration (FDA) for safety and effectiveness.

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What is an FDA Class II Medical Device?

A Class II medical device is a product that requires special controls to ensure its safety and efficacy. These devices are generally more complex than Class I devices and pose a higher risk to the user. For a medical device like the JT10 scooter, this classification means that the FDA has reviewed the product's design, manufacturing process, and performance data to ensure it meets strict quality standards. This designation provides assurance to consumers that the device is reliable and safe for its intended use.

Key Features of the JT10 Scooter

The JT10 is a Travel Scooter that designed with user convenience and comfort in mind, boasting several impressive features:

Easy Disassembly: The scooter can be effortlessly disassembled into five parts without any tools. The heaviest component weighs only 35 lbs, making it lightweight and portable. Once separated, the parts can be easily stored in a car trunk, taking up minimal space.

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Superior Maneuverability and Comfort: The JT10 is equipped with a front and rear suspension system and comes standard with 9-inch pneumatic tires. This combination provides exceptional obstacle avoidance and a smooth, comfortable ride, whether you're on a flat surface or a bumpy road.

Powerful Performance: Powered by a 300W motor, the scooter has a robust weight capacity of 300 lbs.

Extended Range: With two 20AH lead-acid batteries, the JT10 offers a long-lasting range of up to 15.5 miles, giving you peace of mind on your journeys.

Your Opportunity to Connect with JTE Mobility

The FDA's classification of the JT10 as a Class II Medical Device paves the way for its sales in the United States. If you're interested in learning more about this innovative scooter, please don't hesitate to contact JTE Mobility. We are dedicated to providing excellent service and are ready to assist you.

About Us

Welcome to the world of JTE Mobility! We're specialized in the R&D, production and sale of mobility products. It has equipped with professional and technical personnel, advanced production lines and testing platforms. JTE Mobility Scooters are of high quality ,comfort and safety for elderly. The limited speeds, electromagnetic brakes,swivel padded seats, chargeable batteries ,detachable frame provide mobility and travel for old people indoors and outdoors. We produce four series of mobility scooters in folding portable size,detachable small size, suitable medium size and heavy duty size for your right choice. ISO9001:2015, CE certificate, FDA certificate are available to serve European and American markets.

Visit our website: www.jtemobility.com

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Company Name: Jiangxi Jiangte Electric Vehicle Co., Ltd.
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Country: China
Website: https://www.jtemobility.com/