Has your supplier checked if the power chair or mobility scooter is appropriate for you? Has the product you are buying gone through 200,000 repetitive tests? Has the product passed all the appropriate regulatory certification and is ‘fit for purpose’?
We only sell to you if we think it’s appropriate for your needs, we insist our UK agents (at your home demonstration) and/or our UK dealers, conduct mobility assessments with you, in line with BHTA guidance. This way we make sure you only purchase the most appropriate product for you, if it’s deemed appropriate.
WHO IS THE BHTA?
The "British Healthcare Trades Association" are a not-for-profit trade association in the healthcare and assistive technologies arena, working on behalf of members to improve industry standards and consumer protection. Their members (including eFOLDi) are retailers, installers, service providers, distributors and manufacturers who employ over 18,500 people and provide essential equipment and services to both the public and private sectors. Through their interaction and engagement with regulatory and standards-setting bodies, both domestic and international, BHTA is at the forefront of improving standards for the provision of quality healthcare and assistive technology products and services. Each and every BHTA member commits to adhering to their Code of Practice – the first and only code in the healthcare industry to have been approved by the Chartered Trading Standards Institute (CTSI). This code ensures that those who need their members’ products and services can trust that the company is professional, ethical, and has their best interests at heart. To check if a company is a member, Click here. To confirm eFOLDi's membership Click here.
OUR PRODUCT QUALITY ASSURANCE
Can you guarantee that the product you are purchasing is safe, has met the appropriate Governmental regulatory requirements (to be allowed to sell in the UK or other countries) and has been tested to the highest levels to meet MHRA and UKCA (UK), MDR (EU) or FDA (USA) requirements?
All our eFOLDi range have passed the ISO7176/ EN 12184 standards, ensuring their safety, reliability, and performance. Key testing areas include:
1. Mechanical Tests: These assess the strength and durability of the devices, including performance on slopes and stability under load.
2. Electrical Safety Tests: These ensure the electrical systems are safe to use and free from faults.
3. Electromagnetic Compatibility Tests verify that the devices do not interfere with other electronic equipment or affected by external electromagnetic interference.
4. Battery and Charging Tests: These evaluate battery performance, including range and charging time.
5. User Comfort Tests: These assess seat design, suspension systems, and overall riding comfort.
These tests are very strict, and need to be all carried out on one single unit. For example, the same unit needs to be dropped from height 1,000 times before undergoing a vibration test of 200,000 repetitions, all to ensure our eFOLDi electric wheelchairs and mobility scooters can be safely and reliably used in various environments, providing a good user experience.
WHO IS THE MHRA?
The "Medicines and Healthcare products Regulatory Agency" is the regulator of medicines and medical devices in the UK operating under a statutory framework set by HM UK Government within the Department of Health and Social Care, working within government and the wider health system to direct overall policy in our regulatory field. Its policies establish a role in securing public health improvements and gives it the power to deliver against corporate responsibilities. All of our power chairs and mobility scooters meet this requirement.
UKCA
The UKCA marking (an abbreviation of UK Conformity Assessed) is a conformity mark that indicates conformity with the applicable requirements for products sold within Great Britain. The government intended that it should replace the CE marking for products sold in Great Britain. Both markings continue to be accepted in the UK market. All of our power chairs and mobility scooters meet this requirement.
THE EUROPEAN MEDICINES AGENCY (EMA)
Within the European Union (EU) products must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process and for mobility scooters and power chairs they must meet the MDR Medical Devices Regulation (EU) 2017/745. All of our power chairs and mobility scooters meet this requirement.
FDA
The United States Food and Drug Administration is the federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of multiple products including medical devices, such as mobility scooters and power chairs. Our eFOLDi LITE has passed the appropriate stringent tests to be sold as a Medical device in the USA.
OUR BATTERIES
Customer safety is our No. 1 priority, therefore we only work with Tier one battery cell suppliers. Our eFOLDi battery packs consist of supreme power rated cells from Sony, Panasonic or Samsung. All our battery packs have been tested to UN38.3* standards and with MSDS certification to be safely taken on board aeroplanes and cruises.
*UN38.3 details environmental, mechanical, and electrical requirements for all lithium cells and batteries. Manufacturers of lithium batteries and products using lithium batteries must demonstrate compliance in the design, manufacturing and distribution of their products.