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Disclaimer regarding the statements about Luxxamed and micro current therapy
The contents and statements on this website are aimed exclusively at persons who operate the medical devices in pursuit of their commercial, independent professional or professional activity within the meaning of § 14 BGB. (Doctors, physiotherapists, non-medical practitioners) The information is exclusively for this group of people and are not addressed to consumers in the sense of § 13 BGB. Consumers or patients please contact your doctor or therapist.
The Luxxamed devices are medical devices in the sense of the guideline MDD 93/42 / EWG. In accordance with Annex II of the Directive, the conformity assessment procedure for CE marking was carried out and the equipment was approved in the field of pain therapy (acute and chronic) and neurological complaints in the European Union. The clinical performance and effect on the indicated indications, was demonstrated in the context of CE marking, acc. Annex X of Directive 93/42 / EEC (MEDDEV 2.7.1 rev. 04, CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42 / EEC and 90/385 EEC) and has been tested and approved by TÜV Nord.
Patients / Medical Laypersons
The Luxxamed devices have been developed exclusively for the use of professional users and as part of their “approval" (conformity assessment procedure according to Annex II of the MDD MDD 93/42 / EEC) only for this user group in the application are admitted Patients or medical laymen If you have any questions, please contact your doctor or therapist.
Notified Body and Supervisory Authority
Luxxamed GmbH is certified according to DIN EN ISO 13485. The notified body for the inspection of the quality management system and the conformity assessment procedure is TÜV Nord Cert GmbH. The supervisory authority for the marketing of medical devices is the regional council of Kassel.
Health statements on this site
Please note that there are a variety of studies and scientific research on micro-current therapy, LED light and the Luxxamed devices themselves. These studies and studies show the effect of therapy and devices in the corresponding empirically tested areas. The results of these studies will be discussed in the medical community.