Allied Medical Products

Allied Medical Products specializes in single-use cardiopulmonary resuscitation (CPR) masks. These devices are specifically designed for emergency resuscitation scenarios, ensuring a secure seal during chest compressions. Their portfolio includes variations such as masks with and without an integrated oxygen port, as well as sterile versions packaged in clam-shell containers.

Allied Medical Products is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations.

Allied Medical Products’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory requirements.

Allied Medical Products’ CPR masks fall under Class II classification by the FDA. This classification is assigned based on the device’s risk level—Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.

The Class II classification indicates that Allied Medical Products’ CPR masks undergo additional regulatory scrutiny beyond basic safety checks. This includes compliance with specific performance standards (e.g., leak resistance, ease of use) and post-market monitoring to ensure continued safety and efficacy. For healthcare providers, this classification signals that the devices meet stringent requirements for emergency medical use.