Department of Health and Human Services
Public Health Service
April 9, 2012
RETURN RECEIPT REQUESTED
In reply please refer to Warning Letter SEA 12-21
Mr. Fray Adib, President
5870 S 194th St.
Kent, Washington 98032
Dear Mr. Adib:
The Office of Compliance, in the Food and Drug Administration's (FDA) Center for Devices and Radiological Health, has reviewed your firm's print advertisements, brochures, and Internet web sites promoting the K7 Evaluation System, the J5 Myo-monitor, and the BNS-40 Bilateral Neuro Stimulator (BNS-40). FDA determined that your firm manufactures these biofeedback and goniometer products during an inspection of your Kent, Washington, facility from April 25 through May 12, 2011. These products are devices within the meaning of section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), 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 to affect the structure or function of the body.
As a result of our review and the inspection, FDA has determined that your firm is promoting and marketing the K7 Evaluation System, the J5 Myo-monitor, and the BNS-40 with new intended uses in the United States without required marketing clearance or approval, in violation of the Act.
Specifically, FDA cleared the K7 Evaluation System under K003287 for explicitly-identified uses in jaw tracking and electromyographic functions. However, your firm has been disseminating marketing material that includes medical claims that have not been evaluated or cleared by FDA. For example:
- "NOT ALL HEADACHES ARE STRESS RELATED. Do you get headaches often or for no apparent reason? Many headaches are the result of dental problems that can be corrected. If you experience migraines, pain behind your eyes, jaw pain, jaw muscle pain or common headaches, it may be a dental problem."
- "While NMO [Neuromuscular Occlusion] is not proven to treat conditions, other than craniocervical pain of muscular origin, many patients report coincidental improvement in such conditions as migraine, congested ears, tinnitus, numbness in hands and forearms, and even Trigeminal Neuralgia. While such coincidental relief is neither predictable nor documented, there is certainly sound rationale as to why this would be."
Similarly, FDA cleared the J5 Myo-monitor (K031998) and BNS-40 (K842224) devices for specific enumerated intended uses. Your firm, however, has been disseminating marketing material for the J5 Myo-monitor and BNS-40 that includes medical claims that have not been evaluated or cleared by FDA. For example:
Your firm sells a patient education pamphlet entitled, "The Benefit of TENS in Dentistry" and specifically references the J-5 Myo-monitor and the BNS-40. This pamphlet includes the following new intended use:
"To provide drug-free pain relief for your patients. Headaches. " This text is above an image of different type of headaches: sinus, cluster, tension, and migraine.
These devices have not been cleared by FDA for treatment of sinus, cluster, or migraine headaches.
These changes to the intended use of the K7 Evaluation System, the J5 Myo-monitor, and the BNS-40 cause these devices to be 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the 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) 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/cdrh/devadvice/3122.html. FDA will evaluate the information that your firm submits and decide whether the 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.
Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to the Food and Drug Administration, Attention: Brenda L. Reihing, Compliance Officer, Seattle District, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter please contact Brenda L. Reihing at (425) 483-4899.
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. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. 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.
Charles M. Breen
This page was posted on April 18, 2012.