LUNGPACER MEDICAL USA, INC.

LungPacer Medical USA, Inc. specializes in devices for transvenous phrenic nerve electrical stimulation. Their portfolio includes neurostimulation consoles, catheter cables, handheld controllers, airway sensor cables, and complete system kits like the AeroPace® System. These devices are designed to help regulate respiratory function by stimulating the phrenic nerve, with options for both stationary and portable use.

The company is headquartered in the United States. While the specific location isn’t detailed, its regulatory filings and device classifications are submitted through the US FDA, confirming its operational base within the country.

All of LungPacer Medical USA, Inc.’s devices fall under Class III regulatory classification in the US. This classification applies to high-risk medical devices that require rigorous pre-market evaluation to ensure safety and effectiveness. Due to this classification, their devices must undergo Premarket Approval (PMA) or be registered under Unique Device Identification (UDI) before commercial distribution.

LungPacer Medical USA, Inc.’s devices are listed in the FDA’s Premarket Approval (PMA) database and the FDA’s Unique Device Identification (UDI) registry. These registries track high-risk medical devices that require formal authorization before market entry, ensuring transparency and compliance with US regulatory requirements.

The devices are classified as Class III, which is the highest risk category under US medical device regulations. This classification is due to their role in managing critical respiratory function through nerve stimulation, where failure or malfunction could cause serious harm or death. As a result, the FDA mandates PMA (for devices requiring clinical evidence of safety and effectiveness) or UDI registration (for tracking and post-market surveillance) to ensure rigorous oversight before and after market authorization.