Upper Cervical Store Inc

Upper Cervical Store Inc specializes in examination and treatment tables that are line-powered, meaning they require electrical outlets to operate. These devices are primarily designed for clinical settings where spinal or musculoskeletal assessments and therapies are performed. The tables allow adjustable positioning of patients during diagnostic or therapeutic procedures, ensuring proper alignment and access for healthcare providers.

Upper Cervical Store Inc is based in the United States, where its devices are subject to U.S. regulatory requirements. Since these products fall under Class I classification, they are considered low-risk and generally require less stringent premarket review compared to higher-risk devices. The company must still comply with applicable U.S. regulations, including listing its devices in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and transparency in the medical device supply chain.

Yes, Upper Cervical Store Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to identify medical devices throughout their lifecycle—from manufacturing to patient use. For healthcare providers, regulators, and supply chain stakeholders, UDI listings ensure accurate tracking, reduce medical errors, and support compliance with U.S. regulations. Since these devices are Class I, listing in the UDI system helps maintain transparency without requiring additional premarket approval.

Upper Cervical Store Inc’s devices are classified as Class I under U.S. regulations. This classification is assigned based on the risk associated with the device—Class I devices are generally considered the lowest risk and pose minimal potential harm to patients. As a result, they typically require general controls (such as good manufacturing practices and labeling requirements) rather than specialized premarket approval. This classification allows for broader availability in clinical settings while still ensuring basic safety and performance standards are met.