HBOT Chambers & Systems from AHA Hyperbarics
AHA Hyperbarics is an Austrian manufacturer of soft-sided, single-person hyperbaric chambers rated at 1.8-2.0 ATA, headquartered in Vienna with offices in Warrenton, VA (USA) and Kranj (Slovenia). Its EUDAMED manufacturer registration and its FDA establishment registration with device listing are register-verified; its CE (MDD), ISO 13485 and MDR-transition certificates are manufacturer-stated. One caveat: the 510(k) it cites, K101262, was originally cleared to a different company.
Company & Products
AHA Hyperbarics is headquartered in Vienna, Austria, and operates as a multinational with offices in Warrenton, Virginia (USA) and Kranj (Slovenia). The company sells its chambers globally.
The product line consists of soft-sided (flexible) hyperbaric chambers built for one occupant. The datasheets for the AHA Flex medical system state a maximum working pressure of 200 kPa (2.0 bar), and the manufacturer's FAQ confirms operation at 1.8 ATA with a test pressure of 3.6 ATA - we therefore list the operating range as 1.8-2.0 ATA.
Two pressure figures on the manufacturer's site need context. The chambers overview page speaks of medical HBOT at 'at least 1.6 ata and up to 3.0 ata' - the 3.0 figure describes the therapy definition, not the chamber rating. And the FDA-listed US model AHA Flex 20s is stated at 4 psi (approx. 1.27 ATA, mild hyperbaric), while the EU model AHA Flex 20 V2 operates at 200 kPa (2.0 bar) - same product family, different pressure rating by market.
Certifications & Verification
Register-verified: AHA Hyperbarics holds an active EUDAMED manufacturer registration (SRN AT-MF-000023416) and an FDA establishment registration (3013938915) with a device listing for the 'AHA Flex 20s' under 510(k) number K101262. We confirmed both entries directly in the EU and FDA databases.
Sources disagree on the 510(k), however. The manufacturer's certificates page presents K101262 as approval for the AHA Flex 20s, but the FDA register shows K101262 was cleared on 2010-06-10 to the applicant Pressure-Tech, Inc. for a device named 'FLEXI-LITE'. AHA's own FDA device listing does reference K101262, but AHA is not the original 510(k) applicant.
Manufacturer-stated (published by AHA, not independently register-verified): an EC certificate under MDD 93/42/EEC Annex II issued by TUV SUD (Notified Body 0123), an EN ISO 13485:2016 certificate (Q5-104291-0002), an MDR transition confirmation letter from TUV SUD Product Service GmbH, and compliance with EN 14931:2006 (PVHO).
Service & Support
Chambers are delivered and set up by manufacturer staff. Support starts with immediate phone assistance; if that does not resolve the issue, an on-site service technician arrives within 48 hours, according to the company's FAQ. Buyers who purchase for personal use must complete a mandatory operator course (HCO Level 1).
Warranty is a gap: a two-year manufacturer's warranty (or 2,000 working hours) is explicitly stated only for the AHA Oxygen Concentrator. We found no public warranty statement for the chambers themselves - ask for written terms before ordering.
Published B2B references: TSV Hartberg (Austrian Bundesliga football club), O2therapie (Austria), and Summit Sports and Spine (Utah, USA).
Who It Suits
Based on chamber type, pressure and capacity alone: this is a single-person, soft-sided system. It fits practices, sports and wellness facilities, and private buyers who need one occupant per session - not clinics that require multiplace departments or hard-shell chambers at higher pressures.
On pressure, match the model to your market: the EU model AHA Flex 20 V2 operates at 200 kPa (2.0 bar), while the FDA-listed US model AHA Flex 20s is stated at 4 psi (approx. 1.27 ATA, mild hyperbaric) - the same product family carries different ratings by market. The published references (a football club and a sports-and-spine clinic) point to sports and therapy settings, and the mandatory operator course for personal-use buyers signals that home use is an intended market.
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