HBOT Chambers & Systems from OxyHealth
OxyHealth is a US supplier of portable soft and monoplace hyperbaric chambers based in Santa Fe Springs, California, selling worldwide with European distribution via OxyHealth Europe. Its chamber models are register-verified in the FDA 510(k) database under two clearance numbers, and the company holds a verified FDA establishment registration. The same register raises open questions, though: it classifies OxyHealth as a repackager/relabeler, and both 510(k) clearances were originally granted to other applicants.
Company & Products
OxyHealth, headquartered in Santa Fe Springs, California (USA), supplies portable hyperbaric chambers in two categories: soft chambers and monoplace chambers. The models documented in FDA listings are the Solace 210, Respiro 270, Vitaeris 320 and Quamvis 320 under one clearance number, and the Fortius 420/420 EXP under another.
Operating pressures across the lineup range from 1.3 to 3.0 ATA, with a capacity of 1 to 2 persons per chamber. The company states that over 18,000 of its chambers are in use worldwide - a manufacturer figure we could not verify independently. Sales are worldwide; Europe is served through OxyHealth Europe (oxyhealth.eu).
Certifications & Verification
Register-verified: OxyHealth holds an FDA establishment registration (Reg./FEI 3006777109, Product Code CBF, Class II). Its chamber models are listed in the FDA 510(k) register under K041007 (Fortius 420/420 EXP) and K001409 (Solace 210, Respiro 270, Vitaeris 320, Quamvis 320).
Two conflicts are documented in the register. First, the FDA lists OxyHealth, LLC with the establishment type "Repack or Relabel Medical Device", while the company presents itself as the designer and manufacturer of its chambers. Second, both 510(k) clearances were originally granted to other applicants - K001409 to Hyperbaric Technologies Inc. in 2000 and K041007 to Hyperbaric For Life LLC in 2004. A 510(k) under the OxyHealth name is not findable in the database; the company's own site cites K041007 for the Fortius 420 and no number for the soft chambers.
Manufacturer-stated only, not register-verified: a Certificate to Foreign Government (CFG) export certificate and UL certification for the compressor. No ISO certification and no CE marking or EUDAMED entry are documented in our dossier.
Service, Warranty & Pricing
All documented systems are portable; no fixed installation is documented. OxyHealth runs a factory repair-and-exchange program: a flat repair fee of 2,000 USD (2,500 USD for zipper repairs), optional bladder exchange instead of repair, and loaner chambers for 900 USD (not available for the Quamvis 320). Free return shipping applies to the US mainland only - Hawaii, Alaska, Puerto Rico and international customers are excluded.
Warranty terms per the manufacturer: 5 years on all new chambers (parts and labor for defects under normal use), 1 year on a repaired or replaced component after service, and 5 years on new exchange bladders.
OxyHealth publishes no prices. Public reseller list prices (Airpuria, USD) give an orientation: Respiro 270 at $9,900, Vitaeris 320 at $19,900, Fortius 420 at $136,100.
Who It Suits
The lineup is portable, sized for 1 to 2 persons, and spans 1.3 to 3.0 ATA. That profile points to home users, wellness and fitness operators, and practices that want movable single-user systems rather than fixed clinical installations - no multiplace chambers are documented for OxyHealth.
Reference customers named by the manufacturer include the US Special Forces, the International Olympic Committee and over 3,000 physicians worldwide, alongside named practitioners Dr. Jason Sonners, Dr. Nigma Talib and Dr. Tom Moorcroft. All of these are manufacturer-stated and not independently verified.
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