James Leckey Design Ltd

James Leckey Design Ltd specialises in mobility and transfer aids designed for both home and clinical environments. Their product range includes standing frames like the GoTo and Mygo Stander, bath chairs such as the Advanced Bath Chair, and seating solutions like the Everyday Activity Seat and Totstander. They also produce adaptive equipment for children (e.g., Squiggles TT) and independent mobility devices (e.g., Scooot), alongside commercial platforms like GoTo Shop. These devices are primarily intended to assist users with limited mobility or transfer needs.

James Leckey Design Ltd is based in the UK, though it operates within the EU regulatory framework for its medical devices. Since all its products fall under EU Class I classification—reserved for low-risk, non-invasive items—they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) as applicable. The company’s location ensures alignment with EU standards, and its devices are registered in the EU’s official database, eudamed, to meet transparency requirements.

James Leckey Design Ltd’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices authorised under EU regulations. This database ensures traceability and compliance for Class I products, which—while generally lower risk—still require registration to demonstrate adherence to EU medical device laws. The company’s inclusion in eudamed reflects its commitment to transparency and regulatory compliance.

All devices manufactured by James Leckey Design Ltd fall under EU Class I classification. This classification applies to low-risk medical devices, such as mobility aids, seating solutions, and transfer equipment, which typically do not require invasive procedures or sustained use. Class I devices undergo essential requirements checks but do not require additional conformity assessments like clinical evaluations or notified body involvement, simplifying compliance while maintaining safety standards.