Why is the Neurolumen Device FDA cleared not aproved?
Neurolumen FDA Cleared Pain Managment Device
Neurolumen is FDA cleared, meaning it incorporates the same or closely related technology, that has been previously approved by the FDA. The FDA determined it was substantially equivalent to predicate devices. This determination is made by the FDA after a product is submitted. The FDA decides if the product does contain technology that is enough like the previously approved devices that it will pose similar risks to the public. If the FDA make this determination the product then becomes cleared by FDA to market to the citizens of the United States.
FDA approval is used when there is not a predicate device to compare the new or repurposed device. The submitting company will have to file their pre-market approval application with all of the study data and then the FDA will have to determine if that is enough data to prove that the benefits outweigh the risk to the consumer. It will then either ask for more studies to be or it will approve the device to be marketed.
Neurolumen is a next-generation pain relief device which exclusively embodies the super powerful combination of lasers, LEDs and electrical stimulation. It works on all types of pain.
Oklahoma City, OK – August 13, 2018 – Forget high doses of pain killer medications for pain relief. The American Department of Labor has finally found a better and safer alternative for injured employees suffering from persistent and physically limiting pain. All credits go to a chemist-biologist mom who has launched a revolutionary multi-modal medical device which has shown to offer powerful pain relief in just 30 minutes.
Titled “Neurolumen”, the device embodies a robust combination of lasers, LEDs and electrical stimulation in an easy to use wrap which makes it way more powerful than laser-only or stimulation-only pain relief devices. The innovative device has received cleared from both FDA and Intertek and was covered by Reader’s Digest a few years back.
Neurolumen has redefined healing and pain-relief therapies around the world and its official website is bustling with rave reviews from both doctors and patients.
“Neurolumen has been a great asset in my practice. I use it for many neuropathy cases, carpal tunnel, tendinitis, and general pain. Patients love it! They begin to feel the results in the first couple treatments and results seem to last.” – Todd L. Tyminski, DC, DAAPM
“What a relief to finally find help for my chronic foot, knee, back and neck pain. After many years of suffering, my pain is finally becoming tolerable after only a few Neurolumen treatments. The treatments have eased the pain considerably” – Linda R
The invention of Neurolumen stems from a mom’s persistent quest to find a better pain relief solution for her daughter who was down with a shattered vertebrae from a serious accident. Shelly Henry, the mom & inventor behind this revolutionary device, wanted a better solution than high dose pain relief medication which becomes harmful on long-term use. She started with low-level lasers and eventually her experiment with multi-modal technologies propelled her to the invention of an industry-changing pain relief device that houses the synergized power of lasers, LEDs and electrical stimulation.
The Neurolumen machine comprises of 6 wraps, one battery charger and one control unit. Each of the wraps carries 2 laser diodes, 4 light-emitting diodes and 1 or 2 nerve stimulating gel pads. These gel pads are attached to wraps which are applied to ankles, legs or feet.
“Thanks to Neurolumen, my daughter was finally able to overcome the debilitating pain which prevented her from walking again. Today, she is perfectly active, fit, healthy and has recently given birth to a lovely child”, stated Shelly Henry.
Neurolumen device consists of a control unit, six wraps and a battery charger. Each wrap contains two laser diodes, four light emitting diodes and one or two nerve stimulation gel pads. The pads are attached to the wraps and then the wraps are applied to the feet, ankles and legs. After the machine is switched on, the control unit extends up to 30 minutes of TENS (Transcutaneous Electrical Nerve Stimulation), especially engineered LLLT (low-level laser) and LED therapy simultaneously for fast pain relief.
Added to the extremely powerful multi-modal pain relief benefit, another factor that makes Neurolumen stands out is its ability to address all sorts of pain.
“Neurolumen is designed to alleviate pain and swelling associated with various medical conditions including diabetes, neuropathy, vascular disease, arthritis, atherosclerosis, injury and chemotherapy. Put simply, it can address virtually all sorts of pain. Whether you are suffering from cramps or a stabbing pain or aching or spasms or a burning sensation, Neurolumen will be your answer for all.”
Media Contact Company Name: Neurolumen Contact Person: Becky Bays Email:Send Email City: Oklahoma City State: OK Country: United States Website:https://neurolumen.com
The Neurolumen device has not only been cleared once but twice. The FDA wanted to make sure that our clearance was appropriate for our device. And it was, but it allowed us the add to our indications.
Indications for use:
The Neurolumen is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
Neurolumen submitted to the FDA three modalities combine in one device. We incorporated low-level lasers, LEDs and electrical stimulation in an easy-to-use prescription device. The modalities were placed in a padded flexible wrap that can be wrapped and secured around an area, or a patient can lie on it.
