FAQs
Stem Cell Therapy FAQs
FDA Compliance & Patient Safety
Ultimate Medical Group® is committed to providing safe, ethical, and compliant care in accordance with applicable FDA guidelines and medical standards. We prioritize transparency and patient education so individuals can make informed decisions about non-surgical treatments designed to support healing, function, and mobility. The FAQs below address common questions about FDA oversight, treatment safety, and our approach to responsible care.
Yes. The processing kits used are provided by Emcyte Corporation and all of these devices are 501K certified by the FDA. These devices produce some of the highest concentrations of PRP, BMAC & A2M on the market today.
Yes. The processing kit used to produce Micro Fat Stem Cell Injections is provided by Jointech Labs. The device is 501K certified by the FDA.
No. The FDA categorizes “Stem Cell Therapies” as “Biologics”, and Umbilical Cord Stem Cells are regulated by the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. At the present time, the only FDA use of Stem Cell Therapies derived from umbilical cord blood are for blood related conditions such as Leukemia and Lymphoma. Any use of Umbilical Cord Blood for Orthopedic and Neurologic conditions is not approved by the FDA.
No. Exosomes are regulated and need approval for use in human conditions. AT the present time, there is no FDA approved use of Exosomes for Orthopedic and Neurologic conditions.
NO. These products are considered Biologics under section 351 of (PHS ACT), and drugs under sections 201 of (FD&C ACT). Any Clinic offering these products must file an IND application (Investigational New Drug) with the FDA. At the present time, there are no FDA approved products for Orthopedic and Neurologic conditions. Any clinic offering these products without full FDA approval and regulation is in violation.
