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56532 Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Proposed Rules 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572); are approved as Amos for the corresponding provisions
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How to fill out iontophoresis devices - US:

01
Start by gathering all the necessary supplies, including the iontophoresis device, electrodes, and any prescribed medications or solutions.
02
Ensure that the device is properly cleaned and sanitized before each use to maintain hygiene and prevent any risk of contamination.
03
Connect the electrodes to the designated ports on the device, ensuring a secure connection to avoid any interruptions during the treatment.
04
Prepare the medication or solution as prescribed by your healthcare provider. This may involve diluting a specific concentration or mixing different solutions together.
05
Carefully pour the solution into the designated compartment or reservoir within the iontophoresis device, following the instructions provided by the manufacturer.
06
Double-check that all connections and compartments are properly closed and secured to avoid any leakage during the treatment session.
07
Adjust the settings on the device according to your healthcare provider's instructions. This may include setting the treatment time, current intensity, and polarity.
08
Before starting the treatment, ensure that the treatment area (such as hands or feet) are clean and dry. Remove any jewelry or accessories that may interfere with the treatment.
09
Place the treated body part, such as hand or foot, into the designated area or tray where the electrodes are located.
10
Start the treatment by activating the device according to the provided instructions. The device will deliver a safe and controlled electrical current through the electrodes into the treatment area.
11
During the treatment session, relax and allow the device to do its work. Follow the prescribed treatment duration and avoid interrupting or adjusting the settings without consulting your healthcare provider.
12
After completing the treatment, carefully disconnect the electrodes from the device, ensuring that there are no spills or leaks.
13
Clean and store the iontophoresis device according to the manufacturer's instructions, keeping it in a safe and dry place until the next use.

Who needs iontophoresis devices - US:

01
Individuals with hyperhidrosis: Iontophoresis devices are commonly used to treat excessive sweating (hyperhidrosis) in various parts of the body, such as the hands, feet, or underarms. This condition can significantly impact an individual's quality of life, and iontophoresis can be an effective non-invasive treatment option.
02
Athletes or sports enthusiasts: Iontophoresis can be useful for athletes or individuals who engage in intense physical activities, as it can help reduce the amount of sweat produced in specific body areas. This can prevent discomfort, chafing, and potential skin infections caused by prolonged exposure to sweat.
03
People with certain medical conditions: Iontophoresis devices may also be recommended for individuals with certain medical conditions, such as arthritis or localized pain, as a complementary treatment method. The controlled electrical current delivered through the device can help with the delivery of certain medications or therapeutic agents to the affected area, promoting pain relief and healing. However, it is important to consult with a healthcare provider before using iontophoresis in such cases.
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Iontophoresis devices are medical devices that use mild electrical currents to deliver medication through the skin.
Manufacturers, importers, and distributors of iontophoresis devices in the US are required to file with the FDA.
To fill out the required forms for iontophoresis devices in the US, companies must provide information about the device, its intended use, and any known risks.
Iontophoresis devices are used to administer medication non-invasively through the skin, offering an alternative to injections or oral medications.
Companies must report information about the device's design, intended use, materials, and any testing or clinical studies conducted.
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