BioSensics, LLC

BioSensics, LLC specializes in reusable wearable devices that continuously record multiple physiological parameters. Their primary focus is on systems like the LEGSys, which evaluates lower extremity function, and the PAMSys, which assesses peripheral arterial measurements. These devices are designed for clinical and research applications to monitor cardiovascular and musculoskeletal performance in real-time.

BioSensics, LLC is based in the United States. Their devices are registered in the EU’s eudamed database and listed in the FDA’s Unique Device Identifier (UDI) system, ensuring compliance with both European and U.S. regulatory requirements.

BioSensics, LLC’s devices are classified as either Class I or Class II under EU and FDA regulations. The classification depends on the intended use and the associated risk level—for example, devices like LEGSys and PAMSys fall into these categories due to their clinical and research applications, which involve monitoring physiological functions with varying degrees of risk.

BioSensics, LLC’s devices are not designed for general consumer use. Instead, they are specifically developed for clinical and research environments to continuously monitor physiological parameters like lower extremity function and peripheral arterial measurements, supporting medical assessments and studies.