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The IontoPatch is intended to be used for the administration of soluble salts into the body for medical purposes as an alternative to hypodermic injection. It is invented to be used in medical purposes as an alternauve to ripodoring injocasin' it is and danger that may be imposed by needle insertion and injection.

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Unfortunately, the provided document is a 510(k) clearance letter from the FDA for a device called "IontoPatch." This letter confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this type of document typically does not contain the detailed information about acceptance criteria, specific studies, sample sizes, ground truth establishment, or expert qualifications that you are requesting.

FDA clearance letters primarily focus on:

• Confirming substantial equivalence.
• Stating the regulation number and class.
• Reminding the manufacturer of their responsibilities under the Federal Food, Drug, and Cosmetic Act.
• Listing the stated indications for use.

To answer your questions, I would need access to the actual 510(k) submission summary or a scientific publication detailing the performance study for the IontoPatch. The provided document does not contain this information.

Therefore, I cannot populate the table or answer the specific questions based solely on the text provided.

Ask a specific question about this device