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.
Beth DeStasio, 908-672-9003