Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health
9200 Corporate Blvd
Rockville. MD 20850
June 25 2009
IntelSource Group, Inc.
3104 E Camelback Rd #528
Pboenix, AZ 85016
RE: Wellness Pro 2010
Dear Mr. Wolfson:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Wellness Pro 2010 in the United States (U.S.) for new uses without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). FDA reviewed your website, www.electromedtech.com for the Wellness Pro 2010 on June 16,2009, and has also reviewed the WellnessPro Brochure that is available for purchase on your website.
The Wellness Pro 2010 is a device within the meaning of section 201 (h) of the Act, 21 U.S.C. 321(h), 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 are intended to affect the structure or function of the body.
The Wellness Pro 2010 is 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). Your device is also misbranded under section 502(0) of the Act 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution for the new uses discussed below, as required by section 510(k) of the Act 21 U.S.C. 360(k) and 21 CFR 807.81(a)(3)(ii).
Specifically, we cleared your premarket notification (510(k)) for the Wellness Pro 2010, K062616, for relief of chronic, intractable pain, and for adjunctive treatment of post-surgical or post-traumatic acute pain. However, your website and the referenced product brochure state that the Wellness Pro 2010 is effective for the reduction of pain in a "wide range" of specific conditions, such as Alzheimer's and Parkinson's diseases, and can be used for
"injury trauma rehabilitation," "detoxification," and "increased[d] blood flow." Your website also contains ICD-9 codes indicating that the Wellness Pro 2010 can be used for a long list of diseases and conditions, such as "brachial neuritis," "tear lateral meniscus," "urinary incontinence," and "cerebral palsy." These statements represent a major change or modification in the intended use of your device that require a new premarket notification.
21 CFR 807.81(a)(3)(ii).
FDA requests that IntelSource Group immediately cease marketing the Wellness Pro 2010 for unapproved uses such as those described above. You should take prompt action to correct these violation(s). Failure to promptly correct these violation(s) 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 lor civil money penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing what steps you have taken to correct the problem and how you plan to prevent this from happening again. Please list all promotional materials for Wellness Pro 2010 containing claims for unapproved uses such as those described above, and explain your plan for discontinuing such claims. Please direct your response to:
Office of Compliance
10903 New Hampshire Ave.
Silver Spring, MD 20993
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for the Wellness Pro 2010 comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and
This page was posted on January 31, 2010.