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WARNING LETTER

Zona Health Inc. MARCS-CMS 584676 —


Delivery Method:
VIA UPS
Product:
Medical Devices

Recipient:
Recipient Name
Mark Young
Recipient Title
CEO
Zona Health Inc.

3077 Carter Hill Rd
Montgomery, AL 36111
United States

Issuing Office:
"OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality"

United States



December 6, 2019

WARNING LETTER


Re: Zona Plus Device
Refer to CMS# 584676

Dear Mr. Young:

The U.S. Food and Drug Administration (FDA) has learned that your firm is marketing the Zona Plus, a handheld unit that is used to perform isometric exercise by gripping the device handle, in 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.

FDA has reviewed your firm's website (https://www.zona.com)1 and determined that the Zona Plus is adulterated under section 501(f)(l)(B) of the Act, 21 U.S.C. § 35l(f)(l)(B), because your firm does 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) for the device as described and marketed. The Zona Plus is also misbranded under section 502(0) of the Act, 21 U.S.C. § 352(0), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 890.5380 (Powered Exercise Equipment), since the device is also intended to control and/or reduce blood pressure, without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 890.9(a). In addition, Zona Plus is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), and 21 CFR 807.97 and 21 CFR 807.39, because representations on your website create an impression of official approval of your device based on compliance with premarket notification regulations and registration of a device establishment and are misleading.

A review of Zona Health, Inc.'s FDA registration and listing has revealed that the Zona Plus is listed under 21 CFR 890.5380 (Powered Exercise Equipment). Devices classified under 21 CFR 890.5380 Powered Exercise Equipment are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9. However, there is evidence that Zona Plus is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5380 Powered Exercise Equipment, thereby exceeding the exemption at 21 CFR 890.9(a). Generic devices of this type are intended for medical purposes, such as to redevelop muscles, restore motion to joints, or for use as an adjunct treatment for obesity. Examples of generic devices of this type include a powered treadmill, a powered bicycle, and powered parallel bars.

Your firm is marketing the Zona Plus for a different intended use, namely to control and/or reduce blood pressure. Statements that indicate that the Zona Plus is intended to be used to control or reduce blood pressure, including without the use of medications or other activities or treatments, are different from the intended uses exempted under 21 CFR 890.5380. Further, this unapproved intended use raises public health and safety concerns because patients may modify their hypertension treatment plans or stop taking medications based on your firm's statements and the patient testimonials on your website that suggest the Zona Plus will help control and/or reduce blood pressure. To date, your firm has not provided any evidence that supports use of your device to control and/or reduce blood pressure.

Your website contains statements that suggest Zona Plus helps control and/or reduce blood pressure. These include, but are not limited to, the following:

• "Zona Plus - A Smart Device for Blood Pressure Control"

• "Real Stories of People Lowering Their Blood Pressure - Zona Health zona.com"

• "The Zona Plus is a high-tech, software-controlled device that guides you through a patented handgrip therapy personalized to your unique physiology. This patented therapy is clinically proven to lower blood pressure in most people in as little as 4 to 8 weeks. The Zona Plus makes it safe and easy to perform this handgrip therapy in the comfort of your own home and see dramatic results in a relatively short amount of time."

• "HOW SOON WILL I SEE A DIFFERENCE IN MY BLOOD PRESSURE?" "Just like with any therapy, the more consistent you are in doing it, the sooner you'll see results-and the better those results will be. Most Zona Plus users see noticeable results within 6 to 8 weeks when they use the device as recommended, but results may vary. Some users see results in as little as 4 weeks, while for others it may take up to 12 weeks. You may not see any change for a few weeks, but then over a couple of days see your blood pressure begin to decrease. The key is to stick with this therapy and give your body time to adjust to it. The results are well worth it!"

• "HOW MUCH CAN I EXPECT MY BLOOD PRESSURE TO GO DOWN BY USING THE ZONA PLUS?" "Since each person 's starting point and body are different, results will vary from person to person. However, if used as directed, the Zona Plus therapy can produce an average drop of about 15 points systolic and IO points diastolic. Typically, the higher your blood pressure is, the greater the drop will be ... the reduction in blood pressure it produces can be as much as ten times greater than what you may see with other types of handgrip therapy. In fact, one recent study that appeared in the Journal of Hypertension found that participants who performed this type of guided handgrip therapy dropped their blood pressure by an average of 13.7 points in just six weeks!"

• "HOW DOES THE ZONA PLUS HELP LOWER MY BLOOD PRESSURE?" "Research suggests the Zona Plus therapy triggers positive physiological changes in your body that naturally lower blood pressure. Regular use increases the diameter of your arteries, makes your arteries more flexible, and improves "resistance vessels" - where the arteries and veins connect. Over time, doing the Zona Plus therapy regularly remodels your arteries and improves your body's circulatory function. It also changes endothelial dysfunction, a key cause of high blood pressure, and boosts nitric oxide production. The therapy also improves Vagal Tone (your body's "fight or flight" response) and improves vascular function by 225%."

• "Many doctors who are familiar with the Zona Plus use it themselves as well as recommend it to patients to control blood pressure, without medications."

• "You can still get the same blood pressure-lowering results with the Zona Plus without transferring your data to a computer."

Because there is evidence that the Zona Plus is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5380, it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.

FDA has notified your firm several times that statements related to the control and/or reduction in blood pressure exceed the limitations described in 21 CFR 890.9(a). During teleconferences on November 15, 2018, and on February 13, 2019, FDA made clear that the Zona Plus is registered as a class I device and is classified as a type of powered exercise equipment regulated under 21 CFR 890.5380, and, as such, the device may not be intended to control or reduce blood pressure. Following the November 15, 2018, teleconference, FDA explained that a De Novo request may be a suitable regulatory pathway based on the risks associated with the Zona Plus and a proposed indication to temporarily lower blood pressure.

During the November 15, 2018, teleconference, we also requested that your firm remove statements that the Zona Plus controls and/or reduces blood pressure from the device's labeling and marketing materials. We also provided specific examples of such statements. We also specifically requested that your firm remove any patient testimonials linked on your website, where such testimonials speak explicitly or implicitly suggest that the Zona Plus can lower blood pressure or treat a hypertensive condition or suggest the patient's discontinuation or reduction of prescribed blood pressure medications. During these teleconferences, you confirmed that you would "remain in all regulatory guidelines." However, your website still contains statements, including those listed above, that the Zona Plus may be used to control and/or reduce blood pressure.

We note that in 2009, your device was the subject of a 510(k) premarket notification for an intended use of reduction of blood pressure in hypertensive patients. On January 28, 2010, FDA determined that the Zona Plus was not substantially equivalent (NSE) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to any device which had been reclassified into class I (General Controls) or class II (Special Controls), or to another device found to be substantially equivalent through the 510(k) process (including a proposed predicate (K020399) intended for use as a relaxation treatment for reduction of stress and indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions). Without 51 0(k) clearance, the Zona Plus was automatically classified by statute into class III (PMA), under section 513(f) of the Act. Section 515(a)(2) of the Act requires a class III device to have an approved PMA before it can be legally marketed, unless the device is reclassified. As stated in the 2010 NSE determination, "[a]ny commercial distribution of this device prior to approval of a PMA, or the effective date of any order by the Food and Drug Administration reclassifying this device into class I or II, would be a violation of the Act." Your firm continued to list the Zona Plus under 21 CFR 890.5380 as a Powered Exercise Equipment device.

The Zona Plus is also misbranded because its labeling is misleading under section 502(a) of the Act, 21 U.S.C. § 352(a). 21 CFR 807.97 states that any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding. In addition, under 21 CFR 807.39, any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding. Registration of a device establishment or assignment of a registration number does not denote approval of the establishment or its products. Your website contains such representations. Examples include, but are not limited to, the following:

• Image of a computer monitor with graphs of blood pressure measurements and the phrase "FDA Cleared."

• "The Zona Plus is in a category of medical devices that do not require FDA approval. Regardless, we have started the process to become approved by the FDA. At this time the Zona Plus has been cleared by the FDA and maintain [sic] an active listing." "Active listing" is hyperlinked to your FDA Establishment Registration and Device Listing.

In addition to misbranding, these statements further support the false impression that FDA has evaluated and cleared Zona Plus for an unapproved use, i.e., to control and/or reduce blood pressure.

We also note that you are marketing the Zona Plus for an intended use that is similar to the (b)(4) We remind you that 21 CFR 812.7(a) and (d) prohibit the promotion of an investigational device until after FDA has approved the device for commercial distribution and any representations that an investigational device is safe or effective for the purposes for which it is being investigated, respectively.

For a device requiring premarket approval, the notification required by section 5 I 0(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the Agency per 21 CFR 807.81 (b). The kind of information that your firm needs to submit in order to obtain clearance or approval 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.

Our office requests that Zona Health, Inc. immediately cease activities that result in the misbranding or adulteration of the Zona Plus, such as the commercial distribution of the device for the use discussed above.

Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Please notify FDA 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. If your firm does not believe that the Zona Plus is in violation of the Act (as described herein), please include your reasoning and any supporting information for our consideration. Your firm's response should be comprehensive and address all violations included in this Warning Letter.

Your firm's response should be sent to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66, Rm 3657
10903 New Hampshire Ave.
Silver Spring, MD 20993

Refer to the identification number, CMS# 584676, when 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: Misti Malone, PhD at 301-796-2520.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations that exist in connection with your marketed device. It is your firm's responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
 

Sincerely yours,
/S/
Bram Zuckerman, MD
Director
Office of Health Technology 2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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1 Last accessed November 15, 2019.

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