Roggwil, December 16, 2020 – For the US Food and Drug Administration (FDA) authorization process, the 510 (k) authorization process (Premarket Notification Submissions) has been changed to the Article 513 (g) authorization process. This step became necessary because in the process according to 510 (k) no remotely comparable products were identified on the American market. In the 513 (g) procedure, the FDA itself classifies products. This simplifies the approval process for us and enables a faster market launch of the tinniwell in the US.
++ About Resaphene Suisse AG
Resaphene Suisse AG, based in Roggwil, Switzerland, is a medical technology company that was founded in 2015 and has been selling a tinnitus therapy device under the name tinniwell since 2016. Resaphene Deutschland GmbH in Constance, Resaphene UK Ltd. act as further sales companies in London and Resaphene US LLC in the US.
++ Contact for questions:
Resaphene Suisse AG
Mrs. Anke Rauterkus (Chief Executive Officer)
T. +41 714500668