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Impact Cryotherapy manufactures whole body cryosaunas in the U.S. in ISO 9001 certified facilities. The Impact Cryosauna has been evaluated by the FDA under the 513(g) process. The FDA has concluded the Impact Cryosauna is not a medical device. Products manufactured or produced by Impact Cryotherapy are not intended to diagnose, treat, cure or prevent any disease or chronic illness.
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