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Does ADC have official distributors outside of the US?

Yes, ADC has a global distribution network and there may be a distributor in your area! For more information, contact our customer service department and we will be glad to assist you with your international business questions. Click here for contact information

Are ADC devices registered or licensed in other countries?

Yes! ADC maintains licensing and registration in a number of other countries, most notably Canada and the European Union. Information relating to license numbers and CE certificates may be obtained by contacting ADC’s regulatory department.

Some medical devices have a 510(k) number. What is this and do ADC devices have a 510(k) number?

A 510(k) number is a premarket notification number that is required for certain classes of medical devices in the US. Generally, devices that are higher risk require premarket notification to the FDA prior to bringing the devices to market. The 510(k) number is issued once a company has proven that a device is substantially equivalent in performance and safety to other devices already existing on the market. ADC manufactures and distributes a number of devices that require premarket notification, and the 510(k) numbers for these devices are available from our regulatory department.

I notice that some websites promote that their products are FDA approved, but ADC does not. Why?

As mentioned in an earlier FAQ, the FDA does not endorse specific medical devices or medical device manufacturers. Companies that list their products as FDA approved are misbranding these medical devices in violation of the laws and regulations of the United States.

Are ADC’s products FDA approved?

The FDA does not endorse specific medical devices or medical device manufacturers. American Diagnostic Corporation is fully registered with the FDA and in compliance with all state and national regulations governing the manufacture and distribution of medical devices. For information relating to ADC’s registration information, please contact our regulatory department at regaffairs@adctoday.com

I am using an aneroid sphyg and the blood pressure values are too high. What is wrong?

There are a number of things that could be causing you to get higher values. It is possible the blood pressure of the person being measured, is, in fact, higher than believed. Blood pressure is a very dynamic vital sign and responds quickly to both physiological and psychological stimuli. Changes of 40mmHg or more on systolic values are quite common. Make sure the patient has rested for at least 2-3 minutes before taking their BP. Second, make sure you are using an appropriately sized cuff.

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