N E W S L E T T E R
INSIDE : • Safety Barriers Now At Reddy Care SERVICES IN A CLINICALLY SAFE ENVIRONMENT WE ARE A LEADER IN PROVIDING OUR
• What Is Tendinitis? • And More!
• Our Clinics are Now Equipped with a Virus Destroying Air Purifier!
The Molekule Air Pro RX was cleared by the United States Food and Drug Administration (FDA) on April 15, 2020, as a medical-grade air purifier intended for use in destroying bacteria and viruses in the air by exposure to ultraviolet radiation. In response to the public health emergency, FDA issued guidance entitled “Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-2019) Public Health Emergency.” In that guidance, FDA indicated that it believed certain air purifiers may help reduce the risk of viral exposure for patients and health care providers to SARS-CoV-2 (the virus that causes COVID-19) based on the Agency’s understanding of those devices and the virus. Consequently, during the public health emergency, FDA has indicated that it would not object to claims that air purifiers can kill SARS-CoV-2 when they meet certain performance criteria and are labeled appropriately.
According to Molekule, its Air Pro RX satisfies the performance criteria set out in FDA guidance, individually addressing each relevant aspect of the device’s performance under the guidance, including effectiveness against RNA virus MS2 (a proxy virus for SARS-CoV-2). In addition, Molekule has provided supplemental labeling to support the use of the Air Pro RX to destroy SARS-CoV-2 that becomes entrained on the device’s filter. Air purifiers are used in hospital operating rooms nationwide!
Molekule is in both Great Neck and Farmingdale clinics.
Call us to make an appointment. Ph: 516-829-0030
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