Blackbox Remote Patient Monitoring LLC

Blackbox Remote Patient Monitoring LLC specializes in portable electronic devices designed for home health monitoring. Their products include automatic-inflation electronic sphygmomanometers (blood pressure monitors for arm or wrist), pulse oximeters (for measuring oxygen saturation), and electronic stand-on floor scales (for weight tracking). These devices are intended to enable remote patient monitoring in non-clinical settings.

The company is headquartered in the United States. Being based in the US means their devices are subject to FDA regulations, which govern their design, manufacturing, and distribution to ensure safety and performance.

Blackbox Remote Patient Monitoring LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning a standardized identifier, ensuring transparency in the supply chain and aiding in post-market surveillance.

The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA guidelines.