HBOT Chambers & Systems from Perry Baromedical
Perry Baromedical is a US manufacturer of monoplace and multiplace hyperbaric oxygen chambers, headquartered in Riviera Beach, Florida; the company states that it sells to hospitals and clinics worldwide. Six FDA 510(k) clearances for its Sigma chamber line are register-verified. Its ISO 13485, MDSAP, CE PED, UKCA and ASME credentials are manufacturer-stated only - and the ISO 13485 certificate displayed on the company's own website showed an expiry date of 2025-03-30 at our retrieval date of 2026-07-22.
Company & Products
Perry Baromedical is a US manufacturer of medical hyperbaric oxygen chambers, headquartered in Riviera Beach, Florida, USA. The current product line covers monoplace and multiplace systems (per the manufacturer's product page, retrieved 2026-07-22). Operating pressures across the range span 3 to 6 ATA, documented in the Sigma Elite and Sigma MP brochures, and capacity runs from 1 patient in the monoplace Sigma Elite up to 18 patients in the largest standard multiplace configuration.
Sources disagree on multiplace capacity: the product page lists standard 2, 3, 4, 6, 8, 12 or 18 patient configurations plus larger custom builds, while the Sigma MP brochure lists 6, 8, 12 or 18. We use the conservative maximum of 18 and do not count unspecified custom builds.
Certifications & Verification
Register-verified: Perry Baromedical holds six FDA 510(k) clearances confirmed in the FDA database - K072427 (Sigma Series monoplace), K990927 (Sigma 3400 monoplace), K974868 (Sigma Plus monoplace), K983648 (Sigma Plus/II multiplace), K930748 (Sigma MP multiplace) and K862198 (Sigma II dualplace).
Manufacturer-stated only: the company claims ISO 13485:2016 (BSI cert FM-703045-001), MDSAP (BSI cert MDSAP-678472-001), CE PED Module B and Module D (BSI certs CE-512611 and CE-512612), UKCA PER Module B/D (BSI certs UKCA-752578-1/UKCA-752579), an ASME Certificate of Authorization No. 26722, a National Board of Boiler and Pressure Vessel Inspectors Certificate of Authorization, and ASME PVHO-1 / NFPA 99 design compliance. None of these could be verified against an independent register.
Sources disagree on current ISO status: the about page claims the company is 'ISO 13485:2016 certified', but the BSI certificate displayed on its own certifications page shows an expiry date of 2025-03-30 - lapsed at our retrieval date of 2026-07-22. The displayed MDSAP certificate is valid to 2028-03-30, while the CE PED Module D and UKCA PER Module D certificates show expiry 2026-01-31. All non-FDA credentials are therefore treated as manufacturer-stated.
Service, Warranty & References
The manufacturer states it sells worldwide to hospitals, private clinics, medical teaching institutions, critical access and children's hospitals, and burn institutes. Support is run as in-house factory service (per the manufacturer's services page): code-compliant facility design and installation, annual chamber maintenance with multi-year service plans, emergency on-site service within 24-48 hours, acrylic tube replacement, and equipment relocation.
Warranty is 12 months from date of delivery against defects in materials and workmanship, with extended warranty and service programs available - note this figure comes from the Sigma MP brochure and is not confirmed for the full product line.
Documented installations from the company's own history page include Simon Fraser University, British Columbia (first multiplace system, 1981), St. Mary's Hospital, West Palm Beach, Florida (first Sigma II acrylic multiplace, 1986), and Columbia Hospital Corporation wound care clinics in Louisville, KY and Macon, GA (1996). All three are manufacturer-stated references.
Who It Suits
Everything in the dossier points to clinical buyers: monoplace and multiplace chambers, operating pressures of 3 to 6 ATA, configurations up to 18 patients, and in-house facility design plus 24-48 hour emergency service. This is equipment for hospital hyperbaric departments, wound care centers and clinics that need single-patient or multi-patient throughput under medical supervision.
The documented range gives no indication of a home or wellness line: the manufacturer's product page lists monoplace and multiplace types, and the documented pressure and capacity figures are specifications for staffed clinical installations. Wellness studios or hotels looking for soft mild-HBOT chambers will not find them in this manufacturer's documented product range.
Every data point on this profile is source-checked. Certifications are only marked as verified when confirmed in official registers - never on manufacturer claims alone.
- FDA 510(k) database
- EUDAMED registry
- Manufacturer filings