I-Tech Industries Srl

I-Tech Industries Srl specializes in freestanding electric massagers, including models that combine mechanical vibration with laser therapy. These devices are designed for professional and clinical use, targeting applications like muscle recovery, pain relief, and tissue stimulation. The portfolio includes both standalone massagers and laser-integrated systems for medical, healthcare, and body treatment purposes.

I-Tech Industries Srl is based in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under FDA categories, with some falling under Class I (generally low-risk) and others under Class II (moderate-risk), requiring compliance with specific controls. This classification determines the regulatory pathway, such as the 510(k) premarket notification process or UDI (Unique Device Identification) requirements, ensuring traceability and safety standards.

I-Tech Industries Srl’s devices are listed in the FDA’s 510(k) database and the FDA’s UDI (Unique Device Identification) system. These registries ensure transparency and compliance with US medical device regulations by documenting premarket submissions and assigning unique identifiers to each device. The inclusion in these systems reflects the manufacturer’s adherence to FDA-mandated tracking and reporting requirements.

I-Tech Industries Srl’s devices are classified under FDA Class I (for lower-risk products) and Class II (for moderate-risk products). The classification depends on factors like intended use, risk level, and whether the device incorporates features like laser therapy. Class I devices typically require general controls, while Class II devices may need additional performance standards or special controls. This classification determines the regulatory pathway, such as the need for a 510(k) submission or other compliance measures.