Zynex Obtains ISO-13485 Certification
Mar 18, 2008 09:20:01 (ET)
LITTLETON, Colo., Mar 18, 2008 (BUSINESS WIRE) -- Zynex Medical Holdings, Inc. (ZYNX, Trade ), a provider of pain management systems and electrotherapy products for medical patients with functional disability, has received it's ISO13485 : 2003 certification for it's compliance with international standards in quality assurance for design, development, manufacturing and distribution of medical devices.
Thomas Sandgaard, CEO, commented: "This certification is not only important as an assurance that we have the appropriate quality systems in place but also crucial to our efforts for international expansion as many countries around the world require this certification as part of their regulatory approval."
Zynex was audited by Orion Registrar, a Colorado corporation authorized by the International Organization for Standardization (ISO).
About Zynex Medical Holdings, Inc.
Zynex Medical Holdings, Inc. (founded in 1996) engineers, manufactures, markets and sells its own design of electrotherapy medical devices in two distinct markets: standard digital electrotherapy products for pain relief and pain management; and the NeuroMove(TM) for stroke and spinal cord injury (SCI) rehabilitation. Zynex's product lines are fully developed, FDA-cleared, commercially sold, and have been developed to uphold the Company's mission of improving the quality of life for patients suffering from impaired mobility due to stroke, spinal cord injury, or debilitating and chronic pain.
Safe Harbor Statement
Certain statements in this release are "forward-looking" and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain additional capital in order to grow our business, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement from insurance companies for products sold or rented to our customers, our dependence on third party manufacturers to produce our goods on time and to our specifications, the acceptance of our products by hospitals and clinicians, implementation of our sales strategy including a strong direct sales force and other risks described in our 10-KSB Report for the year ended December 31, 2006.
SOURCE: Zynex Medical Holdings, Inc.
Zynex Medical Holdings, Inc.
Thomas Sandgaard, 303-703-4906
CEO
