Ergo-Flex Technologies receives FDA 510(k) Clearance for revolutionary medical device

Ergo-Flex Technologies LLC, a leading innovator in the healthcare industry, is thrilled to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking medical device, Back On Trac (BOTGEN1) and Cervi-Trac.

This clearance marks a significant milestone for the company and paves the way for the introduction of a game-changing solution in the healthcare market.

The FDA’s 510(k) clearance is granted to medical devices that demonstrate substantial equivalence to legally marketed predicate devices. This regulatory approval illustrates Ergo-Flex Technologies’ commitment to safety, efficacy and rigorous compliance with FDA regulations. The company’s cutting-edge technology has undergone extensive testing and meticulous review by the FDA, ensuring its readiness to improve patient care, enhance healthcare outcomes and revolutionize medical practices.

“Our team is thrilled to have received 510(k) clearance from the FDA for our innovative medical device,” said Linda Anderson, CEO at Ergo-Flex Technologies. “This milestone validates our unwavering dedication to developing breakthrough solutions that positively impact patient care and change the healthcare landscape. We are excited about the potential this clearance brings and the value it will deliver to healthcare providers and patients alike.”

Ergo-Flex Technologies’ newly cleared medical device, Back On Trac (BOTGEN1) and Cervi-Trac, leverages state-of-the-art technology to address a critical need in the healthcare field.  This device and the Cervi-Trac accessory offer a unique set of features and benefits that will significantly improve patient outcomes, streamline healthcare workflows and enhance overall quality of care. With this clearance, Ergo-Flex Technologies is well-positioned to disrupt the market and set new industry standards.

The Back On Trac (BOTGEN1) is intended for use in professional healthcare facilities, to relieve pressure on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder). The device may be used to manage and reduce pain associated with facet syndrome, herniated disc, protruding disc, extruded disc, sciatica, spondylosis (degenerative disc disease and facet syndrome) and joint pain.

The Cervi-Trac is also intended for use as an accessory to the Back On Trac (BOTGEN1) in professional healthcare facilities to relieve pressure on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac focuses specifically on the cervical region.

“We got it because we were looking for something we could implement to help patients with low back conditions that weren’t responding to things we were currently using in our office. We had a lot of patients with bulging discs and sciatic issues that just weren’t responding to typical care,” said Kala Eulitt, DC, of the Pain and Sciatica Center of Texas.

“Since getting that, after the first three months my staff came to me and said, ‘Doc, patients are getting great results. We are backed up; we need another one.’ So, we got a second Back On Trac unit. Fast-forward another three months; we continue to grow, we are seeing more patients, helping harder conditions. We are getting referrals from neurosurgeons now with non-surgical cases where they have disc problems and other issues that we can now help because of the Back On Trac.  We just got our third Back On Trac in less than a year; in addition to that and an increase of patients that we are able to help, we’re taking over an additional 1200 square feet next to us and moving all of the therapy equipment over there.”

“Back On Trac treatment is amazing. Any tightness in my lower back would go away after each treatment. The way it stretches and moves right to left really releases any tight muscles and gets them ‘back on track.’  Treatment really works,” said Collin S., a Back On Trac patient.

The Back On Trac (BOTGEN1) is fully automated, offers 21 protocols and has no body entrapment system. It has a 35-second patient setup time and a small footprint that can fit into any practice setting.

About Ergo-Flex Technologies

Established in 2011, Ergo-Flex Technologies LLC is the developer, manufacturer and distributor of innovative equipment for chiropractic and therapeutic healthcare professionals that provide extraordinary results for patients experiencing chronic pain.

While our vision started in 2011 from a personal need to relieve back pain, it quickly turned into a mission to share our personal health improvements with as many people as possible.

Over the years, we have grown by providing technologically advanced, patented products that offer innovative solutions to healthcare professionals and non-surgical pain relief for thousands of patients.