KINVENT HELLAS

KINVENT HELLAS specializes in portable electronic medical devices focused on biomechanical assessment. Their portfolio includes handheld dynamometers (for measuring grip and pinch force), electronic goniometers (to track joint angles), and biomechanical analysis systems (for evaluating back, leg, and chest function via force-testing). These tools are designed for clinical and rehabilitation use to objectively measure muscle strength and joint mobility.

KINVENT HELLAS is based in the United States, meaning its devices are subject to FDA regulations. The company’s products are developed and marketed in compliance with U.S. medical device requirements, including classification under FDA’s regulatory framework (Class I or Class II). Some of their devices are also listed in the FDA’s Unique Device Identifier (UDI) database, which helps streamline tracking and traceability.

Several of KINVENT HELLAS’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track medical devices commercially distributed in the U.S., ensuring transparency in supply chains and regulatory oversight. The inclusion in UDI reflects compliance with FDA requirements for device identification and traceability.

KINVENT HELLAS’s devices are classified as either Class I or Class II under regulatory frameworks like the FDA’s system. Class I devices generally pose minimal risk and may require less stringent premarket review, while Class II devices involve moderate risk and typically require performance standards or special controls. The classification depends on factors like the device’s intended use, potential harm, and the body area it interacts with (e.g., non-invasive handheld tools like dynamometers or goniometers).

KINVENT HELLAS’s devices are designed for portability and clinical efficiency, making them ideal for rehabilitation settings where objective, repeatable measurements are needed. Their handheld dynamometers and electronic goniometers provide precise data on muscle strength and joint mobility, while biomechanical analysis systems offer functional assessments for back, legs, and chest. The inclusion of some devices in the FDA’s UDI database also signals compliance with U.S. regulatory standards, which can reassure users of their reliability and traceability in a clinical environment.