Hyperbaric Chambers for Clinics, ASME PVHO-1 Certified

Both terms overlap, but the operative distinction is regulatory. A medical-grade hyperbaric chamber for clinical use must carry ASME PVHO-1 certification (required under NFPA 99 Chapter 14) and be classified as a Class II medical device. A “commercial hyperbaric chamber” typically refers to hard-shell chambers built for multi-patient or professional settings, as opposed to home soft chambers. Every MACY-PAN hard-shell clinical model meets both definitions and carries ASME PVHO-1:2023 certification.

The FDA regulates the manufacturer, not the user. Any clinic or health professional operating a hyperbaric chamber must consult their state and local regulatory agencies and comply with the following: a physician order for each HBOT patient; and a patient room meeting NFPA 99:2018 (or the current version) and NFPA 99 Chapter 14, housing a PVHO-1 certified chamber (refer to your state facility requirements). The fire marshal enforces the ASME / NFPA / facility-specific aspects of HBOT operation. MACY-PAN has completed the FDA clearance processes required to sell into the United States market, you may request 510(k) compliance details from the company.

The HE5000 multiplace chamber has a footprint of 165 × 207 × 175 cm, with a door measuring 500 × 1,160 mm. Allow clearance around the unit for entry and for clear movement during an emergency, at least 91 cm on all sides. Consult your AHJ regarding their specific fire-prevention, safety, and monitoring standards, and consult your facility engineer to evaluate the building infrastructure your new HBOT chamber requires, such as oxygen monitoring, ventilation, and electrical to satisfy NFPA 99. MACY-PAN provides the standard installation drawings your local AHJ requires to secure permitting.

For a single-provider outpatient facility weighing monoplace chamber price against throughput, the HP2202 monoplace chamber (2.0 ATA, 75–90 cm diameter, 180–220 kg) offers the lowest initial purchase cost and a streamlined permitting process. For a dedicated wound care center, an oncology support program, or any practice averaging eight or more patient-sessions a day, the HE5000 multiplace chamber (1–5 patients, 2.0 ATA) is the superior value, yielding 3–5× more revenue per chamber run and allowing clinical staff to accompany patients, often necessary for high-acuity patients, children, and those experiencing treatment-related anxiety. A 2026 Advocate Health study demonstrated higher treatment adherence with multiplace chambers versus monoplace, owing to the social presence and continuous clinical staff support provided to patients.

AHJ authorization is governed by NFPA 99 Chapter 14, which requires compliance with ASME PVHO-1. ASME PVHO-1 lists no country of origin, it is solely a standard of compliance. MACY-PAN hard-shell clinical hyperbaric chambers comply with the most current version, ASME PVHO-1:2023. On request, each client’s compliance package includes the original certification of design, SGS material test reports, CE marking, and ISO 13485 quality-system certificate, exactly the documentation your AHJ, malpractice insurance underwriter, and accreditation body require. It’s not the country of manufacture; it’s the country of compliance. Some AHJs may ask for additional detail on equipment sourced outside the U.S., and the MACY-PAN full compliance file covers this.

Yes. The MACY-PAN clinical sales department is pleased to assist with payment plans and offers in-house financing to qualified clinic purchasers. This factory-direct in-house financing avoids the mark-up added by the payment programs many U.S. distributors offer. Ask us for a detailed clinic price quote covering warranty and spare parts.