Electromedical Technologies Receives Key Medical Device Certification
Electromedical Technologies, Inc. (OTCQB: EMED) has successfully passed the ISO 13485:2016 recertification audit for Medical Device and Quality Management Systems. This certification highlights the company's commitment to quality and safety in its production of bioelectronic devices for pain relief. The company is currently in Phase 2 of developing the WellnessPro POD, a professional-grade wearable device aimed at mass-market retail customers. The effectiveness of this device will be tested before submission to the FDA for 510(k) clearance.
- Passed ISO 13485:2016 recertification audit, enhancing credibility.
- Currently developing WellnessPro POD, targeting pain relief market.
- Future success dependent on FDA approval for WellnessPro POD.
SCOTTSDALE, 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.
An 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.
Matthew 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 conditions during the current COVID-19 pandemic. This is making the Opioid health crises even worse. We believe our offerings are primed to serve as the go-to alternative that uses physics instead of drugs to relieve pain."
About Electromedical Technologies
Headquartered in Scottsdale, Arizona, Electromedical Technologies, Inc. is a commercial stage, FDA cleared, bioelectronic medical device manufacturing company initially focused on the treatment of various chronic, acute, intractable, and post-operative pain conditions. Through University collaboration agreements, the Company is working to develop a comprehensive research program in defining the effects of electro-modulation on the human body. By studying the impacts of electrical fields in cell signaling and effects on virus assembly and immune responses, the Company's goal is to reduce pain and improve overall human wellbeing. The Company's current FDA cleared product indications are for chronic acute post traumatic and post-operative, intractable pain relief. For more information, please visit www.electromedtech.com. Nonhuman preliminary studies that we are planning to start in the near future and their applications are not related to our current product in any way and currently not cleared in the US.
Safe Harbor Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance or guarantee that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: adverse economic conditions, competition, adverse federal, state and local government regulation, international governmental regulation, inadequate capital, inability to carry out research, development and commercialization plans, loss or retirement of key executives and other specific risks. To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.
Corporate Contact:
Electromedical Technologies, Inc.
Hanover International
Tel: 1.888.880.7888
Email: ir@electromedtech.com
https://electromedtech.com
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SOURCE Electromedical Technologies, Inc.
FAQ
What is the significance of Electromedical Technologies passing the ISO 13485:2016 recertification audit?
What is the WellnessPro POD being developed by Electromedical Technologies?
What are the next steps for Electromedical Technologies after the ISO certification?
How does the WellnessPro POD relate to the existing Wellness Pro+ device?
What does the future hold for Electromedical Technologies regarding FDA approvals?
