Source: https://www.casewatch.net/fdawarning/prod/2009/microcurrent.shtml
Timestamp: 2019-04-24 02:38:15+00:00

Document:
During an inspection of your firm located in Seattle, Washington conducted on July 20 through July 22, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Bio-Therapeutic, Inc., Platinum Nano™ Microcurrent System (bt-nano), and the Bio-Therapeutic, Inc., Bio-Ultimate Platinum® Microcurrent System (BUP). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection and a review of our records revealed that you have not obtained marketing approval or clearance before you began offering for sale the bt-nano and the BUP device, which is a violation of the law. Specifically, the bt-nano and the BUP are adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The bt-nano and BUP are also misbranded under section 502(0) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. § 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Your response should be sent to: Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter, please contact Lisa M. Elrand at (425) 483-4913 (telephone) or (425) 483-4760 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360
 § 360
 § 807