HBOT Chambers & Systems from Tekna Manufacturing
Tekna Manufacturing is a US-positioned maker of monoplace and multiplace hyperbaric chambers operating at 3.0 to 6.0 ATA with capacities from 1 to 24 persons. Two FDA 510(k) clearances covering its Hybrid 3200 and Model 5000 chambers are register-verified, though both are filed under the applicant Hypertec, Inc. rather than Tekna. Most other certifications, including ISO 13485 and CE marking, are manufacturer-stated and could not be confirmed in official registers.
Company & Products
Tekna Manufacturing (hyperbaric-chamber.com) presents itself as a US manufacturer of hyperbaric chambers. Its lineup covers monoplace chambers for single occupants and multiplace chambers for groups, with operating pressures between 3.0 and 6.0 ATA depending on the model and capacities ranging from 1 to 24 persons.
One register finding complicates the US positioning: the only current FDA establishment registration with a 'Chamber, Hyperbaric' device listing under the Tekna name (registration 3013595329) belongs to Tekna Manufacturing Pvt. Ltd. in Chennai, India - no active US registration under 'Tekna' was found in the FDA register.
Certifications & Verification
Two FDA 510(k) clearances relevant to Tekna's chambers exist in the official register: K002795 for the Hybrid 3200 monoplace and K002794 for the Model 5000 multiplace, both cleared on 2000-12-06. Both, however, are filed under the applicant Hypertec, Inc. (Deer Field, IL) - not a single 510(k) in the register runs under the name Tekna, while the company's website claims 'FDA 510(k) cleared since 12/07/2000'.
The 510(k) claim also does not extend across the product range: product pages for the Hybrid 4000 and Model 8400 DL advertise 'FDA 510(k) Cleared', yet among all 69 register entries for hyperbaric chambers (product code CBF) there is no entry for a Hybrid 4000, 7200 or 8400 - only the Hybrid 3200 and Model 5000 are covered.
All remaining certifications are manufacturer-stated only: ASME / PVHO-1 / National Board, NFPA-99 code compliance, ISO 9001:2015, ISO 13485:2016 with MDSAP, a CE MDD certificate, a PED CE certificate with design examination for the 3200/5000/6000-7000 series, an IECEE CB test certificate and IEC 60601-1 / -1-2 / -1-6 test reports. The CE MDD claim could not be verified: no Tekna entry was found in EUDAMED, and the MDD has been superseded by the MDR since 2021 - though EUDAMED registration is not fully mandatory for legacy devices, so the absence is not proof of a false claim.
Service & Support
Tekna states worldwide delivery and installation, with direct sales in the USA and international distributors elsewhere. A published annual general maintenance (AGM) program covers recalibration for Class A/B/C HBOT systems, fire-suppression system checks per NFPA-99-2015 and certified acrylic inspection. Published service rates include 475 USD per service or installation day, 475 USD for an acrylic inspection and 450 USD for in-service training (as listed on the website); chamber purchase prices are not published.
Named installations include Midwest Hyperbarics (two Model 6000 multiplace chambers), TN Hyperbaric Centers (a 6-person multiplace built in 2009) and Bioaeris (a Hybrid 3200 monoplace, customer since 2000).
Who It Suits
Judged strictly on the positioning data the dossier contains - chamber type, pressure and capacity - Tekna's range spans single-person monoplace units and multiplace chambers for up to 24 occupants, all operating between 3.0 and 6.0 ATA. A monoplace treats one person per session, while the largest multiplace configurations accommodate up to 24 people at once - a scale only relevant to operators running group sessions. The dossier does not state which market segments Tekna targets, and it contains no information on chamber construction type.
Given the register conflicts documented above, prospective buyers should request the underlying certificates directly from the manufacturer and verify the regulatory status of the specific model they intend to purchase.
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