Manufacturer · Argentina

HBOT Chambers & Systems from BioBarica

2x FDA 510(k) verifiedCE / ISO 13485 (manufacturer-stated)
BioBarica hyperbaric oxygen chamber
At a Glance

BioBarica is an Argentine manufacturer of single-person hyperbaric chambers sold under the Revitalair 430 name, operating at an adjustable 1.1 to 1.45 ATA and distributed through a partner network the company puts at more than 60 countries. Two FDA 510(k) clearances (K171899 and K220290) are register-verified; the CE marking, ISO 13485 and eight national registrations remain manufacturer-stated. Documented B2B references include a chamber in use at a Buenos Aires public hospital since 2018 and a 2019 procurement by Union de Mutuas M.C.S.S. No 267 of Castellon, Spain through public tender.

Key Facts
Chamber TypesMonoplace, Soft-sided
Operating Pressure1.1-1.45 ATA
Capacity1 person
Price RangeEUR 38,000 excl. VAT (Spanish public contract, 2019); US dealer list USD 45,000-59,850 (Revitalair 430F, 2026)
Service AreaWorldwide; partner network in 60+ countries
Installation & MaintenanceAssisted installation, safety and maintenance audits, preventive diagnostics and training; remote CustomerCare+ support
Warranty2 years (public contract; manufacturer datasheet states 3 years)
B2B ReferencesHospital de Quemados, Buenos Aires (public hospital, since 2018); Union de Mutuas, Castellon, Spain (tender 65/2019)
Company

Company & Products

BioBarica is a hyperbaric chamber manufacturer based in Argentina. Its catalogue is built around the Revitalair 430 series - single-person chambers offered in monoplace and soft-sided configurations. No multiplace systems are listed. Every model seats exactly one person, and the cabin working pressure is adjustable between 1.1 and 1.45 ATA according to the official Revitalair 430F datasheet.

Sources disagree on the maximum pressure: BioBarica's own product page and FAQ cite 1.5 ATA, while the datasheet and a Spanish public supply contract both specify a working pressure of 1.45 ATA. The 1.5 ATA figure appears to be the setting of the exhaust relief valves rather than the cabin working pressure, so this profile adopts the conservative 1.45 ATA.

Certifications

Certifications & Verification

BioBarica holds two FDA 510(k) clearances that we verified directly in the FDA register: K171899 for the Revitalair 430F, filed by applicant Oxavita Srl of Buenos Aires, and K220290 for the Revitalair 430+.

Everything else on the certification list is manufacturer-stated, meaning it carries no register verification in our dossier: a CE marking listed as 'CE 2460' (the dossier does not document what the 2460 designation refers to), ISO 13485, ANMAT registration in Argentina, plus registrations with COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru), the health ministries of Uruguay, Egypt and Indonesia, and the Medical Device Authority of Malaysia. The company also states compliance with PVHO-1, ASME and NFPA standards. Manufacturer-stated does not mean false - it means buyers should request the certificates before contracting.

Pricing

Pricing & Warranty

BioBarica publishes no prices. Two documented data points exist: a 2019 Spanish public supply contract priced one Revitalair 430 - including compressor and oxygen concentrator - at EUR 38,000 excl. VAT, and US dealer Rehabmart lists the Revitalair 430F at USD 45,000-59,850 (2026).

Warranty terms are contradictory: the official 430F datasheet states 3 years for all components, while the 2019 Spanish contract fixes 2 years. Following our conservative rule, this profile lists 2 years.

Service

Service & Support

Distribution is worldwide through a partner network the manufacturer puts at more than 60 countries. Stated support services include assisted installation, safety and maintenance audits, scheduled preventive diagnostics and technical training. Notably, routine maintenance is performed by the operator and monitored remotely through the Biobarica Global System (BGS) online software; additional remote support runs via Biobarica CustomerCare+. All of this is manufacturer-stated.

Fit

Who It Suits

With single-person capacity and a working pressure of 1.1-1.45 ATA, the Revitalair line points to outpatient clinics, wellness and fitness operators, and practices running single-patient sessions - not to facilities that need multiplace chambers or higher-pressure systems.

The dossier documents two B2B references, and they differ in what they prove: the public Hospital de Quemados 'Dr. Arturo U. Illia' in Buenos Aires has had a chamber in use since 2018 - the only reference documenting actual clinical use - whereas for Union de Mutuas M.C.S.S. No 267 of Castellon, Spain the record covers only the procurement, a Revitalair 430 sourced through public tender 65/2019 via distributor E-Medika Chambers S.L.

Verified Data

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.

Sources we verify against
  • FDA 510(k) database
  • EUDAMED registry
  • Manufacturer filings