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FDA Commences Review of Cell MedX's Premarket Notification (510K) and Health Canada Renews Class II Medical Device Licenses for eBalance(R) Systems
FDA Commences Review of Cell MedX's Premarket Notification (510K) and Health Canada Renews Class II Medical Device Licenses for eBalance(R) Systems.
About this update from Stimcell Energetics Inc.
[{"type":"text","content":"Carson City, Nevada--(Newsfile Corp. - November 15, 2021) - Cell MedX Corp. (OTCQB: CMXC) (\"Cell MedX\" or the \"Company\"), a biotech company focusing on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness, is pleased to announce that the U.S. Food and Drug Administration (FDA) has acknowledged the receipt of the premarket notification (510K) for the eBalance® Home System and eBalance® Pro System. The submission is in the initial review stage and the Company has received an anticipated request for additional information. The eBalance® Pro System and eBalance® Home System, are microcurrent electrotherapy systems intended to administer a specific variety of therapeutic microcurrent algorithms for temporary relief of pain associated with sore/aching muscles in the shoulders, waist, back, neck, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household-or work-related activities, as well as for general relaxation. The eBalance® Pro System is intended for use by professionals in the clinical setting and the eBalance® Home System is intended for home use by laypersons. In addition, on October 26th the Company received confirmation from Health Canada that the Company's EBALANCE HOME SYSTEM licensed under Licence No. 104925 and EBALANCE PRO SYSTEM licensed under Licence No. 105044 as Class II Medical Device Systems have been successfully renewed, which allows the Company to continue to sell both systems in Canada under the Company's Manufacturing ID: 142793.The Company's EBALANCE trademark number 1867918 and issued certificate of registration number 1,104,935 registering the trademark EBALANCE in the name of the Company will be added to the documentation for Health Canada as an amendment in 2022. The Company's applications to register EBALANCE as a trademark in the United States, which the Company filed with the United States Patent and Trademark Office on December 11, 2017, continues to be under review. About Cell MedX Corp. (OTCQB: CMXC) Cell MedX Corp. is a biotech company focused on the discovery, development and commercialization of therapeutic and non-therapeutic products that promote general wellness and alleviate complications associated with medical conditions including, but not limit...