RESMED MOTOR TECHNOLOGIES INC.

ResMed Motor Technologies Inc. specializes in mandible-repositioning sleep-disordered breathing orthoses. These devices are specifically designed to treat obstructive sleep apnea by repositioning the jaw during sleep, helping to maintain open airways and improve breathing patterns.

ResMed Motor Technologies Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution within the region.

The devices produced by ResMed Motor Technologies Inc., such as mandible-repositioning orthoses, fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as design reviews and performance testing.

Yes, the devices manufactured by ResMed Motor Technologies Inc. are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory, clinical, and market surveillance purposes, ensuring transparency and traceability in the healthcare system.