The world leader in Instrument delivered chiropractic care, Neuromechanical Innovations (NMI), was recently issued EC certification enabling the sale of its products as a Class II Medical Device throughout Europe. The Full Quality Assurance certificate was received following independent audit and assessment of NMI's Quality System in which NMI designs, develops and manufactures the Impulse family of adjusting instruments in accordance with Annex II, Section 3.2 of the Medical Devices Directive 93/42/EE.
International cities were added to the company's Impulse Adjusting clinical training tour with venues adding in Barcelona (Spain), Amsterdam (The Netherlands), Durban (South Africa) and four Australian cities to its 2012 World Tour (listed below). NMI's postgraduate education courses are approved for twelve hours of continuing education co-sponsored by the Postgraduate Division of New York Chiropractic College.
The Chandler, Arizona based medical device manufacturer adds the new CE Mark designation of its product line to its growing list of accolades in the medical device certification arena. The company was certified in its compliance of ISO 13485: 2003 for the design and development, manufacture and distribution of spinal manipulation and mobilization devices. In 2010, NMI received the prestigious UL-Listing for its two chiropractic adjusting instruments, Impulse and Impulse iQ from Underwriters Laboratories, Inc. (UL). Neuromechanical is the first and only manufacturer or distributor of chiropractic adjusting instruments to receive the UL-Listing mark and among few in the chiropractic industry with such designation.
Neuromechanical Innovations' CEO, Christopher J. Colloca, DC reflected on the company's international expansion saying, "Today, there are more chiropractors located outside of the United States than our home country. So, we took the necessary steps to be in compliance with the governmental regulations around the world. This due diligence has added to the strength of NMI as a leader in the international chiropractic movement."
The Impulse Adjusting Instrument, Neuromechanical's first release, received its US FDA 510(k) registration in 2003 and has exponentially grown to now be in use in over 7,000 chiropractic offices in every state in the USA and over 42 countries around the world. Dr. Colloca credits the unprecedented growth of Impulse to its prospective development and evidence base. Prior to its launch, human and animal studies were undertaken to quantify the instruments effect on vertebral motion and physiological benefits. In 2008, the company released the Impulse iQ Adjusting Instrument, that is equipped with a computerized sensor to detect spinal motion responses in real time during chiropractic treatments while gauging its biomechanical performance to the body's response, termed Auto-Sense Technology. Over 20 research publications have been published on the scientific background behind the inventions.