Quell QE-001 User Manual
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Contents
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Quell® User Manual Quell Customer Care 1-800-204-6577 or +1-781-890-9989< Contents |41APPENDIX L: Declaration of ConformityAPPENDIX LDeclaration of ConformityProduct IdentificationProduct name Model/numberQUELL Transcutaneous Electrical Nerve Stimulator QE-001 Quell 1 DeviceQE-002 Quell 2 DeviceQE-P01 ElectrodeQE-P02 Sport ElectrodeManufacturerName of company Address Representative CE Certificate NumberNeuroMetrix, Inc. 1000 Winter St.Waltham, MA 02451U.S.A.Rainer Maas G1 16 10 40014 014European Authorized RepresentativeName of company Address Telephone/emailEMERGO Europe Prinsessegracht 202514 AP The HagueThe Netherlands+31.70.345.8570 – phone+31.70.346.7299 – faxeurope@emergogroup.comNotified Body (Annex II Products Only)Name of company Address Telephone/emailTÜV SÜD Product Service GmbHNotified Body Number 0123ZertifizierstelleRidlerstrasse 6580339 München, Germany+49.89.5008.4477 – phone+49.89.5008.4327 – faxmedical_devices@tuev-sued.deConformity AssessmentDevice classification Route to compliance Standards appliedQE-001QE-002Class IIaRule 9Annex II w/o (4) of MDD93/42/EEC Council DirectiveIEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-10IEC 62304ISO 14971QE-P01QE-P02Class 1Rule 1Annex VII of MDD93/42/EEC Council DirectiveISO 10993NeuroMetrix, Inc. declares, under our exclusive responsibility, that the above mentioned products meetthe provision of the Council Directive 93/42/EEC for Medical Devices until the expiration of the abovereferenced CE certificate.Company Representative: Rainer MaasTitle: Director of QA/RA/Compliance Signature:Date: March 14, 2017Place: Waltham, Massachusetts |
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