The electric lift enables patients with paralysis, injured legs or feet, or the elderly to safely transfer between beds, wheelchairs, seats, and toilets. It greatly reduces the work intensity of nursing staff, improves nursing efficiency, and reduces nursing risks.
Electric wheelchairs provide another possibility for the elderly and disabled people to travel.With the surge in demand for wheelchairs, hospital beds, and electric lifts in the EU market and the US market, EU CE and US FDA applications for electric lifts, electric wheelchairs, electric hospital beds, toilets, and bath chairs have also increased.
In recent years, the problem of global population aging has become increasingly severe, with more and more cases of mobility difficulties caused by diseases. The demand for medical devices such as wheelchairs and commuters has been growing, with the US market being particularly prominent.In 2021, the import volume of wheelchairs in the United States was 193 million US dollars, of which China's export volume was 99 million US dollars, making it the main supplier of imported wheelchairs in the United States, accounting for 51.2% of the total.From 2009 to 2021, the production of electric wheelchairs and electric scooters in China has been increasing year by year, from 564000 in 2009 to over 2 million in 2021, with a compound growth rate of about 12%. In 2020, the export volume of electric wheelchairs in China reached 332400, with an export amount of 183 million US dollars. It is expected that electric wheelchairs and electric scooters will continue to maintain high growth in the future.The above data shows the prospects and advantages of the electric wheelchair market in the United States. Therefore, more and more Chinese manufacturers are applying for FDA registration, hoping to occupy a place in the US market.However, according to FDA regulations, wheelchairs and scooters are classified as Class II products and must successfully obtain 510 (k) in order to be sold. Due to the various types of wheelchairs, multiple testing items, and high requirements for device technology description, enterprises registering for the first time with 510 (k) often encounter a lot of professional problems.
