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Impact Cryotherapy Leads the Industry with FDA Compliance

July 12, 2016 08:00AM Eastern Daylight Time

Impact Cryotherapy completed the FDA 513(g) process. The cryosauna manufacturer received official confirmation that the Impact cryosauna is not considered a regulated medical device by the FDA.


ATLANTA- (BUSINESS WIRE) Impact Cryotherapy is dedicated to ensuring the highest quality of cryosaunas and services for consumers.  To ensure that Impact continuously complies with all rules and regulations and exceeds market safety standards, Impact formally requested the United States Food and Drug Administration (“FDA”) evaluate the Impact cryosauna under the 513(g) Request for Information process.  The FDA officially confirmed that the Impact cryosauna is not considered a regulated medical device.

Even though Impact’s cryosaunas are not regulated by the FDA as a medical device, Impact believes consumers should be aware of the FDA’s positions and guidance on cryosaunas.  Cryosaunas are not intended to be utilized for the treatment of any type of disease, disorder or illness.  Cryotherapy manufacturers and operators should avoid any misleading statements about the use of cryosaunas.

The Impact cryosauna is designed to complement health and wellness initiatives, without treating any medical diseases, disorders or illness. “For Impact, the industry growth warrants continuous study and product development to ensure that safety is paramount in everything we do,” says Richard Otto, Co-founder and CEO at Impact. Impact receives continuous feedback from our customers about the benefits of using the Impact cryosauna.  Collaborating with our customers, Impact continues to enhance the cryosauna with the highest manufacturer standards for a quality product that is safe and supports our customers.

As always, Impact is dedicated to providing the most up to date information regarding cryosaunas. Click here to learn more information about the FDA’s Consumer Guidance regarding cryotherapy and compliance.

To learn more about whole body cryotherapy, contact us at or 404-445-4992.

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Impact Cryotherapy

53 Perimeter Center East
Suite 230
Atlanta, GA 30346