ZYTO has always had a collaborative relationship with the FDA and continues to work closely with them to make sure all our products and marketing materials are 100% compliant with all applicable laws and regulations. This means that you can always be assured that our hardware and software are both completely safe to use and effective, and that any claims we make do not exceed the scope of FDA regulations.
The ZYTO Hand Cradle has gained official 510(k) clearance from the FDA1, and we can confidently say that its safety and accuracy is the best in the industry.
Protecting you from harmful food, drugs, and devices
The US Food & Drug Administration, or FDA, was established early in the 20th century. The precursor to its creation was the Pure Food and Drug Act of 1906, which prohibited the interstate transport of food that was reduced in quality or strength, decomposed, filthy, damaged, or injurious to health. This act also extended to drugs that were similarly adulterated, mislabeled, and misbranded.2
The USDA Bureau of Chemistry was initially responsible for examining adulterated food and drugs, but eventually these powers were handed over to the newly created Food & Drug Administration in 1930. Later acts expanded the scope of the FDA to areas such as monitoring efficacy claims of drugs and medical device regulations. The Medical Device Regulation Act of 1976 established the classification of medical devices based on comparative risk.3
FDA-cleared for measuring galvanic skin response
The ZYTO Hand Cradle is registered by the FDA as a Class II Medical Device. This means that it is more complex than a Class I device and is therefore subject to a more stringent approval process.
While Class I devices include simple things like elastic bandages and tongue depressors, Class II includes devices like pregnancy testing kits, powered wheelchairs, and blood-pressure monitors. Furthermore, the ZYTO Hand Cradle is categorized as a neurological device by the FDA. Other examples of these types of devices include:
- Tuning fork
- Percussor
- Biofeedback device
- Echoencephalograph
- Computerized cognitive assessment aid
- Near Infrared brain hematoma detector
- Ataxiagraph
- Nystagmograph4
The Hand Cradle’s rigorous approval process
While considered a slightly higher risk than Class I devices, the risk Class II devices pose in terms of safety and accuracy is mitigated by the rigorous testing and FDA clearing process they have to go through. For example, the ZYTO Hand Cradle was tested against a predicate galvanic skin response device for accuracy. Data was plotted graphically with this comparison test and the responses were substantially the same.5
Independent third-party tests were also performed on the Hand Cradle, and the device met or exceeded all requirements in accordance with EN60601-1-2 and EN55011 Class B Part 15 regulations. These requirements included passing a radio frequency disturbances and limits test, surge test, magnetic field immunity test, voltage dips and interruptions test, and electrostatic discharge test, among meeting other requirements.6
In short, these and other tests found that the ZYTO Hand Cradle is non-invasive, completely safe to use, and has no known contraindications. This means that the device is safe for infants, children, and adults of all ages to use, including those who have pacemakers or are pregnant. Furthermore, you can connect to the Hand Cradle device without needing to remove jewelry or turning off your cell phone. These outside sources do not affect the responses of the scan whatsoever.
ZYTO’s continued FDA compliance
Being FDA compliant not only means that you can trust the accuracy and safety of the ZYTO Hand Cradle, but also that we work closely with the FDA to make sure that our products and messaging are compliant.
In 2015, we changed some of the verbiage in the ZYTO software based on input from the FDA to avoid any claims that could be interpreted as a medical diagnosis. ZYTO technology is not, nor was it ever, intended to diagnose, cure, or treat any disease or medical condition, and this update in verbiage attempts to clear up any misconceptions to the contrary.
As ZYTO President & COO Kami Howard stated in 2015, “We welcome this input from the FDA. We have a strong desire to represent ZYTO products to our customers accurately and clearly.”
In 2016, we made a voluntary update to the Select and Elite software to modify and remove any features that could be interpreted as exceeding 510(k) clearance claims. This voluntary update shows that we are proactive in our compliance with the FDA as we focus on providing practitioners and business owners with individualized data to help them and their clients make the best wellness decisions.
The clear choice for safety and effectiveness
If you are considering adding decision-support technology to your wellness business or practice and safety and effectiveness are important to you, ZYTO is the clear choice. No other galvanic skin response, bioimpedance, or electrodermal screening device has been tested so thoroughly.
We invite you to learn more about ZYTO and discover the advantages our technology offers by following the links below:
About Dr. Vaughn Cook
Dr. Vaughn R Cook is the Founder & CEO of ZYTO. An Oriental Medical Doctor (OMD) and licensed acupuncturist, he has worked in the complementary and alternative medical field for more than 30 years, specializing in applications that integrate Western and Eastern medicine.
Sources:
1. “510(k) Summary.” US Food & Drug Administration. Accessdata.fda.gov.
2. “History of the Food and Drug Administration.” Wikipedia. En.wikipedia.org.
3. “PMA Approvals.” US Food & Drug Administration. Fda.gov.
4. “CFR – Code of Federal Regulations Title 21.” US Food & Drug Administration. Accessdata.fda.gov.
5. “510(k) Summary.” US Food & Drug Administration. Accessdata.fda.gov.
6. “Medical EMC Testing: Details of IEC 60601-1-2:2014 (Edition 4).” Element. Element.com.
