# FDA WARNING_LETTER - Dzebovskaya, Yelena d/b/a Matrix Health Line - November 08, 2012

Source: https://www.keypedia.com/records/warning_letter/dzebovskaya-yelena-dba-matrix-health-line/277cc18e-b53e-4a27-8429-24aebd0aba9c

> FDA WARNING_LETTER for Dzebovskaya, Yelena d/b/a Matrix Health Line on November 08, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dzebovskaya, Yelena d/b/a Matrix Health Line
- Inspection Date: 2012-11-08
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: The FDA issued a Warning Letter to Dzebovskaya, Yelena d/b/a Matrix Health Line, specifically addressing Michael Pizhadze, regarding the marketing of Cem-Tech Millimeter Wave Therapy (MMV) devices (Cem-Tech, Cem-Tech Mini & Cem-Tech with 30 EHF). The FDA's Office of Compliance reviewed the firm's websites, www.matrixhealthline.com and www.cemworldusa.com, on October 5, 2012.

The FDA determined that the Cem-Tech MMV devices are "devices" under section 201(h) of the Act, 21 U.S.C. § 321(h), due to claims on the websites that they treat conditions such as kidney diseases, cardiac insufficiency, sexual disorders, visual acuity loss, and can cleanse the body of heavy metals, viruses, bacteria, and parasites, normalize the immune system, reduce oncological disease risk, and accelerate healing for stroke and brain hemorrhages.

The devices are deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks an approved premarket approval (PMA) application (section 515(a)) or an approved investigational device exemption (section 520(g

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