Passion For Life Healthcare (Uk) Limited

Passion For Life Healthcare (UK) Limited specializes in mandible-repositioning sleep-disordered breathing orthoses, which are custom-fit oral appliances. These devices are designed to reposition the jaw (mandible) to help manage conditions like snoring and obstructive sleep apnea. Examples include the SnoreLogic system and the Oral Device OA and S variants, which are tailored for clinical use.

The company is based in the United States, though its name includes '(UK) Limited'—this does not indicate a UK regulatory focus but rather a naming convention. Its devices are classified as Class II under US regulations, meaning they require premarket notification (510(k)) clearance and compliance with the FDA’s Unique Device Identification (UDI) system to ensure safety and performance standards are met.

The company’s devices are listed under the FDA’s 510(k) premarket notification pathway and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and compliance with US medical device regulations, confirming that the devices meet applicable standards for mandible-repositioning orthoses.

The company’s devices fall under Class II classification in the US, which means they pose moderate risk and require premarket review (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device. This classification ensures additional scrutiny for safety and effectiveness before commercial distribution, as these devices directly address sleep-disordered breathing—a condition requiring reliable medical intervention.