We purchased a (shenzhen yimi life technologies) finger tip pulse oximeter through (b)(6).I am writing with several concerns: the marketing material on (b)(6) indicated the product would work for adults and children, the marketing materials included with the product indicate for adult use only; the product is labeled rx only but (b)(6) never asked for a copy of a prescription; is (b)(6) vawd certified enabling them to sell prescription devices?; shenzhen yimi life does not appear to have a presence in the u.S.A; the package insert lists validation test results based on a sample of eleven patients; is this sample statistically significant? fda safety report id# (b)(4).
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