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RxAir360 Inc. is presently in the process of applying for 510(k) pre-market notification from the FDA after a successful hydrostatic test of our sophisticated prototype device that we believe has substantial potential within the market. Upon obtaining FDA clearance by early 2025, we are dedicated to providing our device with premium service. As demand escalates, we possess the capacity to augment our production capabilities to accommodate burgeoning market needs. Commencing in 2025, we intend to incrementally enhance our annual production yield, with the prospect of further expansion.
We have retained the services of a well-known successful 510(k) pre-certification entity for clearance to market and sale the device. We are confident that our meticulous approach will facilitate the delivery of a premium-quality product that not only aligns with our customers' requirements but also surpasses their expectations.
Patient treatments are focused on the 15 currently approved medical conditions that are coded for insurance reimbursements. These treatments can also be applied to numerous off-label conditions that require cash payments and are not permitted in hospital facilities in the USA.
Following FDA clearance of our clinical medical device, the initial focus will be directed at 15 medical specialties. These specialties are already treating patients suffering from ailments and diseases where hyperbaric oxygen therapy has been used successfully with positive results for patients.
RxAir360 Inc. is poised to present the RxAir360 mono-place clinical hyperbaric oxygen chamber as an investment opportunity targeted at physicians. This investment offers the potential for immediate returns, which physicians have yet to have the opportunity to leverage. Physicians treating approved conditions are not required to actively seek new patients for their chambers. This class II medical device represents an innovative approach to expanding medical practices and enhancing patient outcomes.
Internal Revenue Service (IRS) Code 179 applies to capital medical device equipment and specifies that a deduction of up to $1,220,000.00 may be made in the first year of purchase.
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