Clinics in Brooklyn, New York

FDA clears hyperbaric chambers as Class II medical devices under 21 CFR 878.5550. FDA has approved hyperbaric oxygen therapy for 14 specific indications aligned with the Undersea and Hyperbaric Medical Society (UHMS). Use for those indications is evidence-based and generally covered by Medicare and commercial insurance when documentation supports medical necessity. Any use outside the 14 approved indications is considered off-label and is not FDA-approved. FDA issued consumer updates in 2013 and again in 2021 warning patients and providers against marketing HBOT for unapproved conditions such as autism, cancer, Alzheimer disease, and long COVID.

• New York Education Law Article 131 (Medicine)
  Governs physician scope, delegation, and advertising standards applicable to HBOT in New York.
• NFPA 99 Chapter 14 (adopted by state fire code)
  Sets facility safety requirements for hyperbaric chamber operation.

The New York Office of Professional Medical Conduct investigates physician advertising complaints under Education Law 6530. The New York State Department of Health licenses Article 28 facilities. CMS MAC National Government Services adjudicates Medicare HBOT claims. The New York Attorney General enforces Executive Law 63(12) and General Business Law 349 against deceptive medical advertising, and has pursued cases against clinics marketing unproven therapies.