MOTORIKA MEDICAL (ISRAEL) LTD

Motorika Medical specializes in rehabilitation systems designed to improve mobility and movement. Their portfolio includes gait rehabilitation systems, such as harness-based devices for lower-limb mobility training, and powered-support systems with virtual-display interfaces for upper-limb rehabilitation. Examples include the REOGO, Optimal-G, and ReoAmbulator, which combine physical support with interactive feedback to assist patients in restoring movement.

Motorika Medical is based in the US, which means their devices are regulated under US medical device laws. The company’s products fall under FDA classification, with individual devices authorised through pathways like clearance or exemption, depending on their risk level and design. This regulatory framework ensures compliance with US standards for safety and performance.

Motorika Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products under US medical device regulations, ensuring transparency and traceability for healthcare providers and regulators.

Motorika Medical’s devices are classified under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls due to moderate risk. The classification determines the regulatory pathway for authorisation, such as 510(k) clearance or exemption, ensuring appropriate oversight based on the device’s risk profile.