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Cell MedX Corp. Files Two Applications for Class II Medical Device Licenses with Health Canada
Cell MedX Corp. Files Two Applications for Class II Medical Device Licenses with Health Canada.
About this update from Stimcell Energetics Inc.
[{"type":"text","content":"Cell MedX Corp. (OTCQB: CMXC), (“Cell MedX” or the “Company”), a bio-tech company focusing on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness, announced today that the Company has filed an application for a Class II Medical Device License for the eBalance Pro System and the eBalance Home System with Health Canada.The applications consisted of the Device License Application and Fee Forms, Labelling and Quality System Requirements: Quality System Certificate for ISO 13485:2016 issued by a MDSAP certified registrar, BSI. The submission was prepared according to Health Canada’s Guidance document – Preparation of Regulatory Activities in the “Non-eCTD Electronic-Only” format and submitted to Health Canada via email.The eBalance Home System and the eBalance Pro System are non-invasive, fully automated microcurrent electrotherapy systems that administer pre-programmed algorithms through the epidermis with the touch of a button for general relaxation and temporary relief of pain.The Company anticipates a response from Health Canada within thirty days. The Company has also been compiling the necessary paperwork for the 510(K) submission to the US FDA.eBalance Pro SystemThe eBalance Pro System includes the eBalance Console which acts as the central controller for three (3) pre-programmed microcurrent algorithms (Wellness, Pain Managementt, & Dual) referred to as Treatment Options. Treatments are administered to patients using Hand Bars, Foot Plates, and/or Pen Probes. The treatment duration and treatment intensity are controlled by the eBalance Console. The Hand Bars and Foot Plates are used for general wellness and pain management while the Pen Probes are used in localized pain management. The eBalance Pro System is a safe, effective, easy-to-use therapeutic option for practitioners who want to deliver frequency-specific microcurrent to clients in their practice.eBalance Home SystemThe eBalance Home System includes the eBalance Console which acts as the central controller for three (3) pre-programmed microcurrent algorithms (Wellness, Pain Management, & Dual) referred to as Treatment Options. Treatments are administered using Hand Bars and Foot Plates. The general wellness and pain management treatment duration and treatment intensity are controlled by the...