Important notification regarding P-STIM devices
Biegler GmbH, as the original manufacturer of P-STIM devices, has learned that products may be sold under the name “P-Stim” that are not FDA-cleared devices manufactured by Biegler GmbH. We have received several complaints about these non-Biegler P-Stim devices. The U.S. Food and Drug Administration (“FDA”) has been advised about this issue, and we want to provide you with information you can use to help confirm that your products are Biegler P-STIM devices:
- The Biegler GmbH P-STIM has BIEGLER typed in red on the paperwork and MEDIZIN ELEKTRONIK is typed below the red BIEGLER logo.
- The Biegler GmbH device is manufactured in Austria.
- The Biegler GmbH P-STIM has the company address on the device and on the paperwork in the package
3001 Mauerbach, AUSTRIA
- The P-STIM logo with an auricular outline drawing is on the device and paperwork.
- The Biegler GmbH package is a clear, 7.5” X 5” container.
- The Biegler GmbH P-STIM device has the European Compliance emblem CE 0123 on the device and on the paperwork.
- The Biegler GmbH P-STIM device package contains a white plastic cap, with a red dot on it that is used with the Biegler GmbH Multi-Point stylus.
- If a device lacks one or more of these features it is not an FDA-cleared Biegler P-STIM device.
Issued November 2013