Respiratory assist devices include devices intended to help patients in need of support for breathing, removal of carbon dioxide, and therapy to reduce disuse atrophy of abdominal wall muscles. The FDA has issued EUAs to help increase the availability of respiratory assist devices, which are integral to treat patients during the COVID-19 pandemic.
The table below lists the respiratory assist devices authorized for use during the COVID-19 public health emergency.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
|Date EUA Issued||Device Type||Letter of Authorization||Fact Sheets||Other Documents||Assigned Product Code|
|04/13/2020||Diaphragmatic Pacing Therapy System (DPTS)||Synapse Biomedical, Inc. TransAeris Diaphragmatic Pacing Therapy System (DPTS)||QPR|
|4/14/2020||Diaphragmatic Pacing Therapy System (DPTS)||QPR|
|04/22/2020||Respiratory Assist Device||ALung Technologies, Inc., Hemolung RAS||QLN|
|05/01/2020||Respiratory Muscle Stimulator||Liberate Medical, LLC VentFree Respiratory Muscle Stimulator Device||QPR|
|07/10/2020||non-Invasive Vagus Nerve Stimulator||electroCore, Inc., gammaCore Sapphire CV||QPR|
|06/30/2021||Incentive Spirometer Accessory||Tidal Medical Technologies LLC, InSee||QOO|