FDA clearance only certifies safe medical devices that really help. You can find many manufacturers of different devices on the Internet which have not undergone any certification (even in the countries where they are manufactured) and still try to sell them, often at a ridiculously low price. Would you buy a car without brake certification? Would you buy a house that no one inspected beforehand? Would you like to have a pacemaker implanted in your heart that does not have FDA approval ?
FDA approved devices will guarantee that you are buying equipment that is safe and truly usable for the purpose it is designed for.
All Electro Antiperspirant® iontophoresis devices have FDA approval and are also certified across Europe (CE Certifications) as medical devices for the treatment of hyperhidrosis / excessive sweating.
There are dozens of devices on the market that have some approval. However, we are most concerned with the safety of such devices. Especially those that have been imported from Asian countries over the past few years and issued as devices with an American or European origin. Such manufacturers have never been granted permission to manufacture and sell healthcare equipment in their own country, let alone in the US. This is simply because not even the designs of the devices themselves are safe.
One company has even recently attempted to sell a simple A / C adapter with an optional current and some electrodes that was used as an iontophoresis device. There is never any protection against electric shock in such a device, and if such an A / C adapter fails, it will be worse than if you put your fingers in an electrical outlet. Such behavior of unprincipled vendors is alarming and it’s painfully obvious that they’re absolutely not concerned about the health of customers.
Keep in mind that tap water iontophoresis (TWI) always combines electricity released into water. Don’t you think it’s better to have approval from US national authorities about the safety of such devices? Every Electro Antiperspirant always has FDA approval as well as a European CE certificate. We’re deadly serious about safety.