Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm477794
Timestamp: 2019-02-24 06:08:11
Document Index: 401704021

Matched Legal Cases: ['§ 321', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360', '§ 360', '§ 381']

Kids Company Ltd Yugengaisha Kids 4/15/15
Johdic Takano
Kids Co., Ltd. Yugengaisha Kids
2nd Floor, 3-3, 1-chome, Nishidai
Itami City, Hyogo 664-0858
Re: PYRO-Energen II and PYRO Nerve Stimulator
Refer to CMS #452601
Dear Mr. Takano:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the PYRO-Energen II and the PYRO Nerve Stimulatorin the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
The FDA has reviewed your website, www.pyroenergen.com, and determined that the PYRO-Energen II and the PYRO Nerve Stimulatorare 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 PYRO-Energen II and the PYRO Nerve Stimulator are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device 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 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Additionally, your firm’s website includes statements that suggest the use of the PYRO Energen II is effective to treat medical conditions such as 1) HIV/AIDS, 2) cancer, 3) herpes, and 4) influenza. However, your firm has not submitted evidence to support these claims to the FDA, nor is the Agency otherwise aware of any evidence that might support such claims.
Our office requests that Kids Co., Ltd. Yugengaisha Kids immediately cease activities that result in the misbranding or adulteration of the PYRO-Energen II and the PYRO Nerve Stimulator, such as the commercial distribution of the device.
Given the serious nature of the violations of the Act, PYRO-Energen II and PYRO Nerve Stimulatorare subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Refer to the identification number CMS #40339when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Debra Demeritt, Chief, Surveillance and Enforcement Branch II at (301) 796-5770 or (301) 847-8137 (fax).
Page Last Updated: 12/17/2015