Disposable Adhesive Conductive Pads - Snaps (Pack of 32 Pads)
which are square 2" x 4" (5cm x 10cm) and have a 510K number K970426 and comply to ISO10993-5 Biological Evaluation of Medical Devices part 5 Test for in vitro cytotoxicity & ISO10993-10. They also have have a Certificate of Registration Quality Management System – ISO 13485:2003 and holds certificate no FM 40363. Company operates a Quality Management System which complies with the requirements of ISO 13485: 2003 for the following scope: The design and development, manufacture and distribution of hydrogel and non-invasive electrodes: Effective date 03/11/2012 -- Expiry Date: 03/12/2015.
Made in Germany for Ion Genius Inc and IELLIOS Inc