Trulife Ltd

Trulife Ltd specialises in ankle-foot orthoses (AFOs) for both adults and children, including adjustable and fixed-frame designs like anterior and lateral AFOs in various sizes. Their product range also covers adjustable crutches for adults and children, wheeled support frames, and domestic height-adjustable frames. These devices are primarily designed to enhance stability and mobility for lower-limb support.

Trulife Ltd is based in the United Kingdom, which means its devices must comply with UK and EU regulatory standards. Since their products fall under Class I medical devices, they are subject to general safety and performance requirements under EU regulations (e.g., MDR/AIMD) and FDA guidelines in the US. The company’s location influences its adherence to these frameworks, ensuring devices meet applicable classification and registration criteria.

Trulife Ltd’s devices are listed in the euamed registry for EU compliance and the FDA 510(k) registry for US clearance. These registries confirm that the devices meet regulatory requirements for market placement. For Class I devices, listing in these systems ensures transparency and compliance with mandatory reporting standards, helping healthcare providers and authorities verify the device’s authorised status.

Trulife Ltd’s devices are classified as Class I medical devices in both the EU and the US. This classification applies to low-risk products like orthoses, crutches, and support frames, which generally pose minimal risk to patients. Class I devices still require compliance with basic safety and performance standards but typically undergo less rigorous pre-market scrutiny than higher-risk categories.