2BREATHE TECHNOLOGIES LTD

2BREATHE Technologies Ltd specializes in biofeedback systems, specifically devices designed to help users manage respiratory function through controlled breathing exercises. Their primary focus is on tools that monitor and train breathing patterns to support respiratory health and stress reduction, such as the RESPeRATE device.

The company is headquartered in the United States. This location influences its regulatory compliance framework, particularly for devices authorized under U.S. medical device regulations.

The company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products, including biofeedback systems like RESPeRATE, which are classified under FDA’s regulatory framework.

The devices produced by 2BREATHE Technologies Ltd fall under FDA Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as biofeedback systems designed for respiratory training.