EINSTEIN WORKS, LLC

Einstein Works, LLC specializes in single-use medical devices primarily focused on emergency and wound care. Their portfolio includes first aid absorbent bandages like *The Emergency Bandage*, non-latex pressure bandages such as *The Emergency Elastic Wrap*, and intraosseous infusion kits like *GO IO* and *NIO Next Generation IO*. These devices are designed for wound protection, fluid administration in emergencies, and medical line management.

Einstein Works, LLC is based in the United States, which means its devices are subject to U.S. regulatory requirements. Since the company’s products are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries, they comply with U.S. medical device regulations, including classification under FDA categories such as Class I and Class II.

Einstein Works, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. The 510(k) process is used for devices classified as Class II, demonstrating substantial equivalence to a predicate device, while the UDI system ensures traceability and identification of all listed devices under U.S. regulatory frameworks.

Einstein Works, LLC’s devices fall under two FDA classification categories: Class I (generally low-risk devices requiring general controls) and Class II (moderate-risk devices requiring special controls to ensure safety and effectiveness). Classification depends on factors like the device’s intended use, potential risks, and regulatory history, with intraosseous infusion kits and stopcocks typically falling into Class II due to their clinical applications.