Business
Electromedical Technologies Receives Key Medical Device Certification
Electromedical Technologies Receives Key Medical Device Certification.
About this update from Electromedical Technologies, Inc.
[{"type":"text","content":"\n\n\n\nElectromedical Technologies Receives Key Medical Device Certification\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nElectromedical Technologies Receives Key Medical Device Certification\nPR Newswire\nSCOTTSDALE, Ariz., Sept. 30, 2021\n\n\n\nSCOTTSDALE, Ariz., Sept. 30, 2021 /PRNewswire/ -- Electromedical Technologies, Inc. (OTCQB: EMED) (the \"Company\"), a pioneer in the development and production of bioelectronic devices designed to relieve chronic, intractable and acute pains by using frequencies and electro-modulation, is pleased to announce that it has passed the ISO 13485:2016 recertification audit for Medical Device and Quality Management Systems. This critical designation demonstrates that the Company's facility meets all of the requirements to design and manufacture medical devices.\nAn internationally recognized standard of quality and safety for medical device industry, ISO 13485:2016 certification affirms EMED's commitment to the highest quality standards from the design phase through production. The Company is currently in Phase 2 of prototype construction of the new WellnessPro POD. The second phase of the process features overall efficacy and product integration testing and is slated to be completed later this Fall. Once complete, the device will be used in a 510(k) medical device submission with the FDA. WellnessPro POD is positioned as a new, smaller, professional grade wearable device for mass market retail customers seeking non-opioid therapy to treat chronic pain and has the ability to work with the flagship Wellness Pro+ device currently in the market. \nMatthew Wolfson, Founder and CEO of EMED, noted, \"We are pleased to announce our successful passing of the ISO 13485 recertification. This designation is a testament to our quality control procedures along with our innovation. We strive to design and manufacture the most effective, non-invasive bioelectronic devices for pain sufferers seeking alternate therapy choices to drugs. Patients suffering from chronic and acute pain have had greater difficulty dealing with their...