PN Medical Inc

PN Medical Inc specializes in devices for respiratory and oral muscle rehabilitation. Their portfolio includes tongue and lip exercisers, such as the Breather Fit, and incentive spirometers like the Breather Recover and Breather Voice. These products are designed to support recovery after surgery, assist in speech therapy, and aid pulmonary rehabilitation by strengthening respiratory muscles and improving lung function.

PN Medical Inc is based in the United States. While the company’s headquarters and primary operations are located there, its devices are listed in international regulatory databases like EUDAMED, indicating compliance with European Union medical device regulations. This suggests the company’s products may be marketed or used in the EU, though the company itself is not based in Europe.

PN Medical Inc’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) database in the United States. These listings help track and verify the devices’ compliance with applicable regulations in those regions.

PN Medical Inc’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and often require general controls for regulation, 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, as outlined in FDA guidelines.