WARNING LETTER
RoyalVibe Health Ltd.
MARCS-CMS 639553 —
November 18, 2022
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Dr. Raymond L. Venter
Recipient Title
CEO
RoyalVibe Health Ltd.
1095 Evergreen Circle, Suite 200
The Woodlands
,
TX
77380
United States
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS: 639553
November 18, 2022
Dear Dr. Venter:
During an attempted inspection of your firm located in the Woodlands, TX on June 17, 2022 through July 5, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm markets, distributes and manufactures the CellQuicken Analyzer (Smart-Watch, and Software), RoyalVibe Ultrasound Generator, Envirovibe Water Restructuring Pad, Brainvibe Neuroplasticity Visual Program, RoyalVibe Therapy Balls, and RoyalVibe Application. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (“Act” or “the Act”), 21 U.S.C. § 321(h), these products are devices 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 are intended to affect the structure or any function of the body.
We have received your response via e-mail dated July 7, 2022, stating you will cease offering the RoyalVibe products for sale in the United States until you have achieved compliance with the regulations. However, your response does not address the previously marketed and distributed adulterated devices. You stated you have approximately
(b)(4)
customers with devices in the United States. Additionally, as of the date of this letter, your firm has several active product websites which appear to offer consumers the opportunity to purchase the products, and your companion software application is still available for download in the United States. In response to this letter, you should provide your plan for addressing the previously distributed adulterated products and provide details on the steps you’ve taken to remove your products from the US market.
The FDA has reviewed your firm’s websites and attempted an inspection and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(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), 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) 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 devices 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 products may be legally marketed.
Your firm markets the above referenced devices as a kit and as individual devices, intended for the diagnosis and treatment of several diseases including but not limited to cancer, Alzheimer’s, ischemic stroke, arthritis, and type 1 diabetes. Your firm’s product labeling includes claims which demonstrate the products are marketed for the diagnosis and treatment of disease. These products are devices under section 201(h) of 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 are intended to affect the structure or any function of the body. For example, your website (www.royalvibehealth.com) promotes your firm’s products for, among others, the following intended uses:
• “Diagnosed Condition’s Root Causes We Can Help Treat
Cancer
Type 1 Diabetes
Type 2 Diabetes
Cardiovascular Disease
Alzheimer’s
Kidney Disease
Liver Disease
Cerebrovascular problems (stroke)
Lung Disease
Depression”
• “Breakthrough Cancer Treatment: A 90% Success Rate without Side-Effects”
In addition, your RoyalVibe (www.royalvibehealth.com) and CellQuicken (www.cellquicken.com) websites contain, among others, claims and instructions for use (IFU) for the following devices:
RoyalVibe Bioresonance Focused Ultrasound Generator
Claims
• “RoyalVibe Health uses ‘Bioresonance Focused Ultrasound’ technology and our therapy protocol help heal from different condition diagnoses, like Alzheimer's, Diabetes, Stroke, Cancer, and many others.”
• “RoyalVibe Health uses a specific ‘Bio-Resonance Ultrasound Healing’ technology to target dangerous and toxic cells and help heal damaged and stressed cells that suffer from stress, bad diet, conventional treatments like chemotherapy, radiation, or other like from inflammation inside the body.”
• “This technology and holistic approach can be effective for various conditions and even cancer stages, including stage 3 and stage 4 cancer.”
• “Does it work for any disease? Bioresonance Focused Ultrasound Treatment uses a sound vibration technology that can resonate with the vibration of any stressed, cancerous or healthy cell in your body. It means that it can help you heal from just about any unhealthy condition or imbalance that you may have within your body.”
IFU
• Screenshot of companion app lists protocols for “treatment Alzheimer,” “Ischemic Stroke,” “treatment Cancer,” and “treatments Arthritis.”
• “The Electro Therapy Balls are used for direct contact. They are typically used to apply frequency directly to affected areas of pain and inflammation.”
• “Connecting cables are used to connect the ultrasound transmitter, as well as the silver therapy balls to your RoyalVibe device.”
Claims or statements that indicate that this product will use sound vibration technology to “resonate with” and heal damaged and stressed body cells, and can treat Alzheimer’s, diabetes, stroke, and cancer show an intent to treat disease or to affect the structure or any function of the body. See Act § 201(h)(2), (3), 21 U.S.C. § 321(h)(2), (3). Based on this, the RoyalVibe Bioresonance Focused Ultrasound Generator product is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.
Envirovibe Water Restructuring Pad
Claims
• “Envirovibe Water Therapy (Heal Your Body Cells From The Inside Out)”
• “Once you turn it on, it starts generating sound vibrations that create a perfectly structured, ready-to-drink water that heals and empowers your body cells in 10 minutes or less.”
• “Water restructuring means the clustering of the water molecules is reduced for better absorbability in the cell.”
• “In simple words – your cell gets more water with less effort, and that is crucial for effective communication and faster healing within your body.”
IFU
• “According to feedback from our clients, in addition to restructuring your water, the EnviroVibe has proven to be incredibly effective for treating pain; inflammation; wounds; broken bones; stomach ailments such as diarrhea or constipation, etc.”
• “For example, you can place your EnviroVibe directly on your stomach and run the “CONSTIPATION SHORT” treatment found on Public Groupings, or place a broken leg on or next to your EnviroVibe and run the “BONE HEALING AND INFLAMMATION” treatment.”
• “Your treatment with your RoyalVibe will be even more effective when there is more cellular communication due to hydration, thus assisting your cells to function at an optimal level. This also ensures faster healing and cell regeneration.”
Claims or statements that indicate that this product will restructure water molecules to increase absorbability and heal body cells and can treat pain, inflammation, wounds, broken bones, diarrhea, and constipation show an intent to treat disease or to affect the structure or any function of the body. See Act § 201(h)(2), (3), 21 U.S.C. § 321(h)(2), (3). Based on this, the Envirovibe Water Restructuring Pad product is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.
CellQuicken Analyzer
Claims
• “‘CellQuicken Analyzer’ is the tool that helps detect the root cause of your condition. It helps you understand why the disease formed in the first place.”
• “‘CellQuicken Analyzer’ is powered with a unique and proven to work ‘Bioresonance Ultrasound Recording Technology’ which analyzer uses to scan your entire body in less than 60 seconds and gives you the exact information about…
o What are the risk factors of your condition
o How fast is it improving or degrading (after more than 1 scan)
o Indicate why did the condition happen in the first place? (the root cause)
o What hormones, vitamins, minerals, or co-enzymes you may be missing or have too much of
o And so much more!”
Claims or statements that indicate that this product will scan the body and detect the root cause of a condition and help a user understand why a disease formed show an intent for use in the diagnosis of disease or other conditions. See Act § 201(h)(2), 21 U.S.C. § 321(h)(2). Based on this, the CellQuicken Analyzer product is a device under 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.
Therapy Balls Spine Alignment
Claims
• “RoyalVibe Therapy Balls’ – a unique set of metal balls specifically designed to treat the nerves that controls the muscles that align the spine.”
• “Not only is it effective for general health, immune system, and such conditions as severe scoliosis, but it also has shown some major pain relief for people with Parkinson’s disease, depression, Glaucoma, headache, Migraine, joint pain, and other mild and severe health conditions.”
Claims or statements that indicate that this product will affect nerves associated with the spine and can treat severe scoliosis and symptoms associated with Parkinson’s Disease, depression, glaucoma, headache, and migraine show an intent to mitigate or treat disease or to affect the structure or any function of the body. See Act § 201(h)(2), (3), 21 U.S.C. § 321(h)(2), (3). Based on this, the Therapy Balls Spine Alignment product is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.
BrainVibe Neuroplasticity Program
IFU
• Screenshot of companion app includes an Audio “Treatment List” for “Addiction Reduction”
Claims or statements that suggest that this product can reduce or treat addiction show an intent to mitigate or treat disease. See Act § 201(h)(2), 21 U.S.C. § 321(h)(2). Based on this, the BrainVibe Neuroplasticity Program product is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the cure, mitigation, treatment, or prevention of disease.
RoyalVibe Application
IFU
• “9. On your RoyalVibe application, log into your Health Advice Hub account on the application. Find your treatment under the correct dependent and run the program.
• “10. If your treatments have been scheduled simply ensure that all devices are on, and programs will run. Scheduled treatments will over-ride any current programs running.”
• “Once you have selected the treatment you want to run, you click on the RUN button at the bottom of the screen”
Claims or statements that suggest that this product (only when paired via Bluetooth with the various products in the kit) can run programs that will treat disease show an intent to treat disease. See Act § 201(h)(2), 21 U.S.C. § 321(h)(2). Based on this, the RoyalVibe Application product is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.
Under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (Act § 510(p), 21 U.S.C. § 360(p)), during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2022.
Therefore, all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360 and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
We also note that an FDA investigator provided you with a Notice of Inspection on June 17, 2022, but you did not permit FDA’s inspection of your establishment located at 1095 Evergreen Circle, Suite 200, The Woodlands, TX, 77530, and you did not respond to the investigator’s subsequent requests to inspect your establishment. You indicated that your firm uses this establishment as an address for customers in the United States to return their products for repair or replacement. Thus, you denied and/or limited an inspection of your establishment where your firm’s devices are processed, packed, and/or held (see Act § 501(j), 21 U.S.C. § 351(j)).
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter 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. Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts.
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 address 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) that 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 any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent to: Jessica Mu, Director of Compliance Branch, at oradevices3firmresponse@fda.hhs.gov. Refer to the Unique Identification Number (CMS#639553) when replying. If you have any questions about the contents of this letter, please contact: Jeff R. Wooley at 214-253-5251.
Finally, you should know that this letter is not intended to be an all-inclusive list of your firm’s violations. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely,
/S/
Shari J. Shambaugh
Program Division Director
Office of Medical Devices and Radiological
Health, Division III
/S/
Binita S. Ashar, MD, MBA, FACS
Director OHT 4: Office of Surgery and Infection
Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
12/27/2022
Regulated Product(s)
Medical Devices