VM/POSITIONING, INC.

VM/POSITIONING, INC. specializes in patient positioning devices, including freestanding supports like the Voss Supine Positioner and Voss PronePositioner, reusable arm procedure positioners such as the Voss Convoluted Arm Board, single-use head/neck immobilizers like the Voss Cervical Laminectomy Harness, and leg/knee cushions including the Voss Cardiac Leg Support. These products are designed to assist in surgical and procedural environments by securing and stabilizing patients in optimal positions.

VM/POSITIONING, INC. is based in the United States, meaning its devices must comply with U.S. regulatory requirements. Since all its products fall under Class I classification, they are subject to general controls under FDA regulations, including registration, listing, and UDI requirements. The company’s domestic location ensures alignment with FDA standards for medical positioning aids, which are reflected in its inclusion in the FDA’s UDI database.

VM/POSITIONING, INC.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a centralized repository for tracking medical devices authorized in the U.S. The UDI system ensures transparency and traceability of devices like the Voss 9" Round Support or Voss Adult Supine Head Rest, allowing healthcare providers and regulators to verify compliance and product details.

All devices from VM/POSITIONING, INC. are classified as Class I under U.S. regulations, which is the lowest risk category for medical devices. This classification applies to products like the Voss Small Bolster or Voss Chest Roll, meaning they are subject to general controls such as proper labeling, manufacturing practices, and registration requirements. Class I devices are typically considered safe and effective when used as intended, with minimal risk to patients.