Saalmann medical GmbH & Co. KG

Saalmann medical GmbH & Co. KG specializes in iontophoresis systems, which are medical devices designed to treat hyperhidrosis—excessive sweating. Their primary product, The Fischer, is an iontophoresis system specifically engineered to deliver controlled therapy for reducing abnormal sweating in targeted body areas.

The company is based in the United States, where it develops and manufactures its medical devices in compliance with applicable regulatory requirements for the jurisdiction.

Saalmann medical GmbH & Co. KG’s iontophoresis systems are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory transparency for their Class II devices.

The company’s iontophoresis systems, including The Fischer, fall under FDA Class II classification. This classification is determined based on the device’s intended use and associated risks, requiring special controls beyond general controls to ensure safety and effectiveness.