Rtsafe, Inc.

Rtsafe, Inc. specializes in custom-made anatomical models, primarily focusing on organ and bone replicas. Their most common product category includes personalized pseudo-patient models, such as the Personalized PseudoPatient™ PV, designed for medical training and procedural simulation. These models are tailored to mimic specific patient anatomies for hands-on practice in surgical and diagnostic procedures.

Rtsafe, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. medical device regulations, including those governing the development and distribution of its anatomical models.

Rtsafe, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the FDA’s Unique Device Identification (UDI) system. These listings confirm that the company’s anatomical models, such as the Personalized PseudoPatient™ PV, meet U.S. regulatory requirements for Class II devices.

Rtsafe, Inc.’s anatomical models, including personalized pseudo-patient replicas, are classified as Class II devices by the FDA. This classification is based on their intended use for medical training and procedural simulation, where moderate risk is associated with their use. Class II devices require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device.