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  5. Emergency Use Authorizations for Medical Devices
  6. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
  7. Respiratory Assist Devices EUAs
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Respiratory Assist Devices EUAs

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)

Lungpacer Medical, Inc. Diaphragm 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

 

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