The Manufacturer of this Red-Light Device has been in business for 10 years and has successfully marketed several hundred units nationwide. The manufacturers desire was to move through the FDA process and to formally receive its clearance as an FDA Cleared Device. After 3.5 years of moving through this tedious process with the FDA, May 2021 the Manufacturer got its clearance as an FDA Cleared Medical Class II device. The manufacturer is now prepared to expand rapidly nationwide. Although MedXPrime’s executive team had been aware of Red-Light Devices in the marketplace for some time, the team remained patient for a company that had a superior product, had a demonstrated clinical study and more importantly had proper clearances from the FDA. As soon as our manufacturer got its clearance in May 2021, MedXPrime entered into an agreement in July 2021 as its “nationwide principal marketing group”.
Our Manufacturer’s distinct differentiator is that its device is FDA Cleared Technology and is THE ONLY PAD-BASED DEVICE THAT HAS AN FDA CLEARANCE FOR CIRCUMFERENTIAL REDUCTION/INCH LOSS. From our understanding there are only two other companies that offer a pad-based device and neither is FDA cleared. The US being the most litigious society in the world, it’s our opinion that incorporating a non-FDA cleared device within a practice could potentially be risky for the operator. Please beware of competing devices that state they are FDA Registered; they are not FDA Cleared nor FDA Approved; this simply means their facility is registered with the FDA.
Business 101 dictates that a manufacturer in business for 10 years that enters into an agreement with a national marketing organization like MedXPrime, would have to substantially increase its pricing in order to compensate MedXPrime and its national independent sales representatives. The Manufacturer and MedXPrime’s executive teams did something that is unprecedented. Because of MedXPrime’s proven record of immediate and massive action, it was agreed the price of the device would not increase, not even by one cent. The manufacturer believes with the volume of business MedXPrime intends to produce nationwide and internationally, the manufacturer agreed to not increase the price, again not even one cent.