Sensory Medical, Inc.

Sensory Medical, Inc. specializes in two primary categories of medical devices: bedside monitor remote-viewing software for non-physiological patient parameters and safe environment patient enclosures. Their product line includes items like Cubby Beds, which provide secure, enclosed spaces for patient care, and the SYMPHONY DEVICE, designed for remote monitoring of specific patient data. These devices are developed to enhance patient safety and care coordination in clinical settings.

Sensory Medical, Inc. is based in the United States. Their devices are regulated under U.S. FDA guidelines, specifically classified as Class I or Class II depending on the product. This classification determines the regulatory pathway, such as the 510(k) premarket notification process and the requirement for Unique Device Identifiers (UDIs), ensuring compliance with U.S. medical device regulations.

Sensory Medical, Inc.’s devices are listed under the FDA’s 510(k) premarket notification program and the UDI (Unique Device Identification) system. These registries help track and identify their products, ensuring transparency and compliance with U.S. medical device regulations. The 510(k) program assesses substantial equivalence to existing devices, while UDIs provide standardized identification for traceability.

Sensory Medical, Inc.’s devices are classified under FDA’s risk-based system as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory requirements, such as pre-market submissions or post-market surveillance, ensuring appropriate oversight for each product.