FOOT SCIENCE INTERNATIONAL LIMITED

Foot Science International Limited specialises in prefabricated orthotic insoles, which are designed to provide foot support. These devices come in two primary variants: antimicrobial and non-antimicrobial. They are intended for general use in managing foot-related conditions, such as pain relief, biomechanical correction, or improved comfort.

The company is headquartered in New Zealand, where its operations and product development are centred. This location influences its regulatory compliance processes, particularly for markets like the EU and the US.

The company’s devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices in their respective markets, helping healthcare providers and regulators verify compliance.

All devices produced by Foot Science International Limited fall under Class I classification. This classification applies to low-risk devices, such as prefabricated orthotic insoles, which pose minimal risk to patients when used as intended. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories.