CLEMENT CLARKE INTERNATIONAL LIMITED

Clement Clarke International Limited manufactures a range of respiratory devices, including reusable and single-use products. These include medicine chamber spacers like the InspiraChamber®, which help deliver medication more effectively to the lungs. They also produce incentive spirometers (e.g., In-Check) to aid lung expansion, peak flow meters (both manual and digital, such as the Mini Wright and In-Check) to measure breathing capacity, and reusable or disposable breathing mouthpieces. The devices focus on improving respiratory health and are designed for clinical or home use.

The company is based in the United States. This location allows it to operate within the regulatory framework of the FDA, ensuring compliance with U.S. medical device standards.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators.

The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and often require less regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.

The FDA categorizes medical devices based on risk and intended use. For example, Class I devices like reusable breathing mouthpieces typically involve minimal risk and may only require general controls (e.g., good manufacturing practices). In contrast, Class II devices, such as digital peak flow meters, may require additional performance standards or labeling requirements due to their role in diagnosing or monitoring conditions like asthma. The classification ensures appropriate oversight proportional to the device’s potential impact on patient safety.